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Managing chronic venous leg ulcers — what’s the latest evidence?

Chronic venous leg ulcers (CVLUs) affect nearly 2.2 million Americans annually, including an estimated 3.6% of people over the age of 65. Given that CVLU risk increases with age, the global incidence is predicted to escalate dramatically because of the growing population of older adults. Annual CVLU treatment-related costs to the U.S. healthcare system alone are upwards of $3.5 billion, which are directly related to long healing times and recurrence rates of over 50%.

CVLUs are not only challenging and costly to treat, but the associated morbidity significantly reduces quality of life. That makes it critical for clinicians to choose evidence-based treatment strategies to achieve maximum healing outcomes and minimize recurrence rates of these common debilitating conditions. These strategies, which include compression therapy, specialized dressings, topical and oral medications, and surgery, are used to reduce edema, facilitate healing, and avert recurrence.

In 2006, the Wound Healing Society (WHS) developed guidelines for treating CVLUs based on human and animal studies; the guidelines were updated in 2015 by an advisory panel of academicians, clinicians, and researchers, all with expertise in wound healing. The guidelines are organized by categories: diagnosis, compression, infection control, wound bed preparation, dressings, surgery, use of adjuvant agents (topical, device, and systemic), and long-term maintenance. Each recommendation is evaluated according to strength of evidence. (See Levels of evidence.)

WHS guidelines provide clinicians with evidence-based treatment recommendations for caring for patients with CVLUs. A summary of the guidelines regarding compression, infection control, wound bed preparation, dressings, and long-term maintenance, is provided in this article. You can access the full guidelines.

Lower extremity compression

External compression has long been the gold standard for treating venous hypertension and the associated edema and ulcerations of the lower extremities. Level 1 recommendations from WHS state to use:

a class 3 (most supportive) high-compression system to enhance healing of CVLUs. Methods of compression include multilayered elastic compression, inelastic compression, Unna’s boot, and compression stockings. Consider patient cost and comfort when choosing the method.

intermittent pneumatic pressure with or without compression dressings to stimulate venous return.

Infection control

Preventing or treating infections as soon as possible are important because overgrowth of bacteria in the wound bed impedes wound healing. The only level I recommendation from WHS in this category is to debride (using sharp, enzymatic, mechanical, biological, or autolytic methods) necrotic or devitalized tissue that can be a source of bacterial growth.

Level II recommendations:

Collect a tissue biopsy or use a quantitative swab technique to determine the type and level of infection in the CVLU.

Prescribe an appropriate topical or systemic antimicrobial therapy based on the findings from tissue biopsy or culture and discontinue the antimicrobial agent when the bacteria is “in balance” (defined as 1 x 105 CFU/g of tissue with no beta-hemolytic streptococci) to reduce the chances of cytotoxic effects or bacterial resistance.

Use systemic gram-positive bactericidal antibiotics to treat cellulitis around the CVLU site.

Reduce bacteria levels in CVLU tissue before trying surgical closure (1 x 105 CFU/g of tissue with no beta-hemolytic streptococci).

Wound bed preparation

Wound bed preparation is used to accelerate healing or to facilitate the effectiveness of other therapeutic measures. To achieve these goals, the level I recommendation from WHS is to document the history, recurrence, characteristics (location, size, exudate, staging, condition of surrounding skin, pain), and healing rate of CVLUs on a regular and ongoing basis to determine if care plans need reassessment.

Level II recommendations:

Complete a comprehensive history and physical examination to assess for factors that may be contributing to tissue damage. These factors include systemic diseases, medications, nutritional status, and potential causes of inadequate tissue perfusion and oxygenation, such as dehydration and cigarette smoking.

Perform maintenance debridement to remove cellular debris, necrotic tissue, excessive levels of bacteria, and senescent cells, which will help create an optimal healing environment.

WHS also makes one level III recommendation, which is to cleanse the wound with sterile water or saline initially and at dressing changes to remove debris. Using increased intermittent pressure to deliver the water or saline solution is acceptable.

Dressings

WHS recommendations are to consider patient activity, wound location, and peri-wound skin quality when choosing a dressing that:

sustains a moist wound environment (for example, a continuously moist saline gauze dressing), which promotes cell migration, matrix formation, and debridement and helps reduce CVLUassociated pain.

diminishes wound exudate and therefore protects skin around the CVLU from maceration.

is cost effective (factor in clinician time, application time, healing rate, and unit cost).

remains in place, reduces shear and friction, and does not cause further tissue damage; adhesives are not required when using compression systems. (Note: This is the only level II recommendation; the others are level I.)

Another level I recommendation is to consider using adjuvant therapies (topical, device, or systemic) if there is no healing progression within 3 to 6 weeks of beginning a treatment plan.

Long-term maintenance

CVLUs are considered long-term problems because of their high recurrence rates, so long-term maintenance is required even after ulcers have healed. WHS guidelines for long-term maintenance and prevention of CVLUs state that patients:

with healed CVLUs should wear compression stockings continually and indefinitely to help reduce venous hypertension— the underlying cause of CVLUs. (Level I recommendation.)

should perform exercises that increase calf muscle pump function on a regular basis. (Level III recommendation.)

A patient-centered care plan developed by a multidisciplinary team that includes evidence-based treatment strategies for CVLUs will produce the best possible healing outcomes and help prevent recurrences of these recalcitrant wounds.

Jodi McDaniel is an associate professor and director of the Honors Program at The Ohio State University, Columbus, Ohio.

Selected references

Alavi A, Sibbald RG, Phillips TJ, et al. What’s new: Management of venous leg ulcers: treating venous leg ulcers. J Am Acad Dermatol. 2016;74(4):643-64; quiz 665-6.

Ashby RL, Gabe R, Ali S, et al. Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial. Lancet. 2014;383(9920):871-9.

Beidler S, Douillet C, Berndt D, et al. Inflammatory cytokine levels in chronic venous insufficiency ulcer tissue before and after compression therapy. J Vasc Surg. 2009;49(4):1013-20.

Bergan JJ, Pascarella L, Schmid-Schonbein GW. Pathogenesis of primary chronic venous disease: insights from animal models of venous hypertension. J Vasc Surg. 2008;47(1):183-92.

Marola S, Ferrarese A, Solej M, et al. Management of venous ulcers: state of the art. [published online ahead of print June 21, 2016]. Int J Surg. doi:10.1016/j.ijsu.2016.06.015.

Marston W, Tang J, Kirsner RS, et al. Wound Healing Society 2015 update on guidelines for venous ulcers. Wound Repair Regen. 2016;24(1):136-44.

Raffetto JD. Dermal pathology, cellular biology, and inflammation in chronic venous disease. Thromb Res. 2009;123(Supplement 4):S66-S71.

Rice JB, Desai U, Cummings AK, et al. Burden of venous leg ulcers in the United States. J Med Econ. 2014;17(5):347-56.

Frequently asked questions about support surfaces

The National Pressure Ulcer Advisory Panel (NPUAP) describes support surfaces as “specialized devices for pressure redistribution designed for management of tissue loads, microclimate, and/or other therapeutic functions.” These devices include specialized mattresses, mattress overlays, chair cushions, and pads used on transport stretchers, operating room (OR) tables, examination or procedure tables, and gurneys. Some support surfaces are part of an integrated bed system, which combines the bed frame and support surface into a single unit.

Support surfaces must be used in conjunction with other interventions, such as nutritional support, skin care, repositioning, pressure redistribution, risk identification, and patient and caregiver education. Although studies have shown that support surfaces can help decrease the incidence of pressure injuries (PIs), there is no evidence showing one brand or type of support surface is better than another.

What does it mean when a support surface is described as reactive or active?

Reactive surfaces, also called reactive/continuous low pressure, may be powered or not powered and can adjust pressure redistribution only when a load (such as the weight of a patient) is applied to it.

An active surface is always powered. Pressure distribution is adjusted mechanically, even when there is no patient on the surface.

What materials are used in support surfaces?

Materials include foam, gel, fluid, and silicone beads. Australian medical-grade sheepskin is also used, but has limited availability in the United States. Some support surfaces have covers made of Gore-Tex® or another material that helps reduce friction.

What do the terms immersion, envelopment, and bottoming out mean?

Pressure redistribution with support surfaces is achieved through immersion and envelopment.

Immersion refers to the fact that as the body sinks into the surface, pressure is redistributed over the entire area of contact and not just the bony prominences. Envelopment is the ability of the support surface to conform evenly to irregularities, such as body contours, linens, and the patient’s clothing, without causing excessive pressure on the body.

Bottoming out refers to the patient’s body sinking in so deeply on the support surface that it rests against the bed frame or another surface, such as a gurney, that lacks sufficient cushioning.

What is microclimate control?

Microclimate control (control of temperature and moisture) is achieved by:

controlling the airflow against the skin by pumping air through minute perforations in the surface cover

increasing the exchange of air between the skin and the surface through the use of porous covers that allow moisture evaporation and body heat dissipation.

This feature keeps the skin cool and dry.

Microclimate control is beneficial for patients who are constantly moist (for example, diaphoretic or incontinent). Excess moisture raises the risk of friction and shear, which can result in skin breakdown. The coolness feature helps avoid higher skin temperature, a risk factor for PIs.

What do the features lateral rotation, alternating pressure, low air loss, and air fluidized mean?

These features are the functional or therapeutic components of a support surface. They can be used singly or in combination.

With continuous lateral rotation, or simply lateral rotation, the surface provides rotation longitudinally (head-to-toe), turning the patient to a set degree, in a set duration, and at a set frequency. Rotation is limited to 40 degrees or less to each side. Lateral rotation does not replace repositioning the patient to address skin issues, nor does it provide pressure redistribution or offloading. Instead, surfaces with this feature help facilitate pulmonary hygiene among patients with acute respiratory conditions.

NPUAP defines alternating pressure as “a feature of a support surface that provides pressure redistribution via cyclic changes in loading and unloading as characterized by frequency, duration, amplitude, and rate of change parameters.” Surfaces with alternating pressure may be mattresses or overlays and are always powered. They can change distribution of load with or without applied load—even when no patient is in the bed. These surfaces have air cells that cyclically inflate and deflate, thus changing the areas of the body under pressure.

Low air loss means that the surface provides flow of air to help manage the microclimate of the patient’s skin.

Air-fluidized surfaces provide pressure redistribution by immersion and envelopment, using a fluid-like medium created by forcing air through silicone beads. Air-fluidized surfaces are expensive and difficult to maintain; beds with these surfaces are usually rented instead of purchased. They are heavier than a standard bed, so are not always suitable to place in older homes.

Air-fluidized beds are often used for patients with multiple full-thickness wounds or who have undergone myocutaneous procedures. They are not typically recommended for a patient with an unstable spine or pulmonary disease. The fluid-like surface doesn’t provide sufficient support for a patient with an unstable spine, and for patients with pulmonary disease, the lack of firm support makes it difficult for patients to cough effectively.

What are general considerations for matching patients to appropriate support surfaces?

It’s important to base the choice of support surface on individual patient needs. (See Determining type of support surface.) For example, consider the patient’s weight, height, and shape. (Bariatric patients must use bariatric surfaces; be aware of the weight limitation of the surfaces.)

Other considerations include:

risk for new PIs

number of current PIs, including severity and location

patient’s activity, mobility (for example, avoid surfaces that might make it difficult to get a patient out of bed), and moisture

risk for falls and entrapment in the bed

appropriateness for the setting (for example, powered surfaces can’t be used in a home without a reliable power source).

Consider contraindications when choosing a support surface. For example, reactive/constant low pressure, reactive/constant low pressure with low air loss, active surfaces with alternating pressure feature, and air-fluidized surfaces are contraindicated for patients with unstable cervical, thoracic, and lumbar spines, and patients with cervical or skeletal traction.

Assess the appropriateness of the choice on a regular basis. For example, a patient with multiple stage 3 PIs that have healed may no longer need the surface with low air loss but can now be placed on a reactive/ constant low pressure surface. If a patient experiences pain or discomfort with a particular surface, consider alternatives.

What are important points to remember when using support surfaces?

Education is key to promote optimal use of these surfaces. Staff such as nurses, certified nursing assistants, and other team members who handle the surfaces, including housekeeping and maintenance staff, all need information on how to use the support surface correctly. Education should extend to families, caregivers, and patients in the home setting.

Although the manufacturer may state an expected lifespan for a product, staff must be taught that the lifespan can be shorter, depending on use. Staff need to be aware of indicators of wear and tear; discoloration; any change in height or thickness of the surface; any break in the seams, cover, zippers, flaps; breakdown of internal components; or presence of foul odor. Deficient products must be repaired or replaced.

Other important points related to using support surfaces include the following:

Ensure the appropriate type and number of linens or liners are used with the surfaces. For example, a liner with a plastic bottom is not ideal with low air loss surfaces because the non-breathable feature of the plastic will not allow the air from the support surface to go through.

Clean surfaces as specified by the manufacturers. If the correct cleaning process is not used, the surface poses an infection risk. Incorrect use of agents, for example using products that destroy the integrity of the cover, also increases the risk of cross-infection.

Most importantly, remember that patients must still be repositioned even if they are in a support surface. An active support surface should be used when frequent manual repositioning is not possible. When possible, avoid positioning a patient with an existing PI on the affected area.

What should facilities use as support surfaces in the OR, ED, and procedure areas?

Support surface options for the OR include air, gel, and high-specification foam mattresses. Consider the patient position required for the procedure when making a selection. There are also pads with pressure redistribution properties that can be used for transport and on ED beds. More research is needed to determine the effectiveness and proper use of these support surfaces. When selecting products to use in these special situations, consider safety, care, and costs.

Understanding support surfaces

Support surfaces are an integral part of PI prevention and treatment. When selecting a surface, the patient’s individual needs, including past experiences with the surfaces, must be taken into consideration. It’s important for clinicians to continuously assess patients for the appropriateness and the functionality of the surface.

Armi S. Earlam is the lead certified wound, ostomy, and continence nurse at Lutheran Medical Center in Wheat Ridge, Colorado.

Selected references

Centers for Medicare and Medicaid Services. National Coverage Determination (NCD) for air-fluidized bed (280.8).

Mackey D, Watts C. Therapeutic surfaces for bed and chair. In Doughty D, McNichol L, eds. Core Curriculum: Wound Management. Philadelphia, PA: Wolster Klower; 2016:362-83.

McNichol L, Watts C, Mackey D, et al. Identifying the right surface for the right patient at the right time: generation and content validation of an algorithm for support surface selection. J Wound Ostomy Continence Nurs. 2015;42(1):19-37.

Moore Z, Stephen Haynes J, Callaghan R. Prevention and management of pressure ulcers: support surfaces. Br J Nurs. 2014;23(6):S36-S43.

National Pressure Advisory Panel. Terms and definitions related to support surfaces. 2007.

National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, & Pan Pacific Pressure Injury Alliance. Prevention and treatment of pressure ulcers: clinical practice guidelines. Osborne Park, Australia: Cambridge Media; 2014.

Herpes zoster: Understanding the disease, its treatment, and prevention

Herpes zoster (HZ, also called shingles) is a painful condition that produces a maculopapular and vesicular rash. Usually, the rash appears along a single dermatome (band) around one side of the body or face.

In most cases, pain, tingling, burning, or itching occurs a few days before the rash. Next, blisters form, scabbing over in 7 to 10 days. In rare cases, the rash is widespread, resembling varicella zoster (VZ, or chickenpox) rash. Pain can range from mild to severe and may be dull, burning, or gnawing. It may last weeks, months, or even years after the blisters heal. Shingles on the face may impair vision or hearing.

According to the Centers for Disease Control and Prevention (CDC), nearly 1 million Americans get shingles each year and one in three have it during their lifetime. Caused by the same virus that causes chickenpox, shingles can occur in anyone who has had chickenpox. Most people who develop shingles have just one lifetime episode, but a small percentage have second or even third episodes.

Risk increases with age. Nearly half of shingles cases occur in people ages 60 and older; about half of those older than age 85 develop shingles. Immunocompromised persons also are at higher risk. About 100 Americans die of shingles-related causes each year, nearly all of them elderly or immunocompromised.

How shingles develops

After a person recovers from chickenpox, the VZ virus (VZV) lies dormant in the cranial nerves, dorsal roots, and sensory ganglionic neurons. If this latent virus reactivates, it moves down the nerve fibers to the skin, where it multiplies to cause the rash. VZV can spread through direct contact with the rash to someone who has never had chickenpox—typically a child, who might then get chickenpox, not shingles.

Complications

Shingles complications are more common in elderly and immunocompromised patients. One in five people with shingles develops postherpetic neuralgia (PHN)—a painful, chronic condition in the area affected by VZV. Typically, PHN lasts longer than 90 days after the shingles rash heals. Pain can be debilitating, leading to activity limitations and decreased quality of life. (See Shingles complications.)

Signs and symptoms

Signs and symptoms of shingles occur in three stages.

Prodromal stage. Before the rash appears, patients may have pain, acute neuritis, burning, itching, numbness, tingling, a stabbing sensation, fever, chills, headache, malaise, fatigue, and extreme sensitivity on one side of body. Depression and stomach upset may occur, too.

Active stage. A unilateral erythematous and maculopapular rash arises in one to three dermatomes, along with malaise, headache, nausea, and fever. Vesicles form within 12 to 24 hours, pustules appear in 1 to 7 days, and crusting occurs in 2 to 3 weeks. Once the crusts fall off, the skin remains erythematous and hyperpigmented or hypopigmented with scars.

Chronic stage. After the rash resolves, PHN may occur. The pain may be constant, brief, or sharp. Pain from constant PHN usually is described as deep; brief pain as shooting or stabbing pain, possibly tic-like. Sharp pain may radiate and can be triggered by light touch.

Diagnosis

Differential diagnosis includes impetigo, contact dermatitis, folliculitis, scabies, insect bites, candidiasis, dermatitis herpetiformis, and drug eruptions. If clinical diagnosis isn’t possible, laboratory tests may be done. The gold standard for diagnosing shingles is a tissue culture, but results may take 3 to 7 days, delaying treatment. The enzyme-linked immune-sorbent assay and additional tests confirm diagnosis. Rapid diagnosis also may be obtained using polymerase chain reaction. Laboratory confirmation is mandatory for pregnant women, newborns, immunocompromised patients, and those with atypical rashes.

Treatment

The goal of treatment is to reduce pain and complications, expedite rash healing, and decrease new lesions. Treatment decreases viral shedding and risk to others in contact with the patient. It should start immediately to avoid cutaneous dissemination, PHN, and other serious complications. Starting antiviral therapy within 72 hours of rash onset reduces PHN risk. In elderly and immunocompromised patients, clinicians must act quickly to reduce the risk of cutaneous or visceral rash dissemination, prevent secondary bacterial infections, and decrease time to healing.

Up to 4% of people with shingles need to be hospitalized for I.V. antiviral therapy (acyclovir or valacyclovir) to treat or help avoid complications related to advanced age, immunosuppression, superinfection, and ocular or visceral involvement. All immunocompromised patients should receive treatment; those with organ transplants or disseminated shingles should be hospitalized for immediate I.V. antiviral therapy. Patients with neurologic complications typically receive 10 to 14 days of I.V. acyclovir therapy and are monitored closely for signs and symptoms of stroke.

In a double-blind study comparing valacyclovir therapy (1,000 mg three times daily for 7 to 14 days) to acyclovir therapy (800 mg five times daily for 7 days), the two regimens yielded similar resolution of cutaneous lesions. Valacyclovir produced a slight reduction in acute neuritis.

Cranial neuropathies should be verified by testing for VZV DNA or antiviral IgG antibody in cerebrospinal fluid. Patients may be treated with oral acyclovir, but those who are immunocompromised or have ophthalmic rash distribution require I.V. acyclovir 10 to 15 mg/kg three times daily for 5 to 7 days.

Supportive care includes use of nonadherent dressings, soothing emollients, cleansing, and compresses to reduce the risk of bacterial superinfection. (See Home care.)

Treating PHN

PHN treatment isn’t definitive. Medications used to manage shingles pain also can be used for PHN. They include antidepressants, analgesics, topical lidocaine or capsaicin, anticonvulsants, gabapentin, divalproex sodium, tramadol, and opioids. Ablation and nerve blocks or stimulators also may be given.

Preventing shingles

The shingles vaccine (Zostavax®) decreases the risk and severity of shingles, as well as the risk and severity of PHN in people who develop shingles after vaccination. It reduces shingles incidence by 64% in persons ages 60 to 69 and by 38% in those ages 70 and older. In persons ages 70 and older, it reduces PHN incidence by 67%.

A live attenuated vaccine, the vaccine is approved to prevent shingles in adults ages 50 and older and is recommended for those ages 60 and older. Studies show it’s safe and effective, with no adverse side effects except headache and minor discomfort at the injection site.

In 2015, Marin et al studied the impact of shingles vaccine in a matched case-control study. Results showed a 58% reduction in prodromal symptoms and a 61% reduction in PHN. This was the first study to show reductions in pain severity and discomfort after vaccination. Further studies are underway to determine if a shingles vaccine can be developed that will maintain its efficacy as the adult ages. A new HZ subunit vaccine (a vaccine free from viral nucleic acid that contains only specific protein subunits of the HZ virus) looks promising in maintaining efficacy at 97% and doesn’t diminish with age.

Contraindications

Contraindications for the shingles vaccine include:

• AIDS or other clinical indications of human immunodeficiency virus

• immunosuppressive therapy (including high-dose corticosteroids)

• hematopoietic stem cell transplantation

• recombinant human immune mediators and immune modulators

• current cancer treatment with radiation or chemotherapy

• bone marrow or lymphatic cancer (such as lymphoma)

• congenital or hereditary immunodeficiency

• pregnancy.

Women should avoid getting pregnant for 3 months after receiving the vaccine. Also, persons with moderate or severe acute illness (including those with a temperature of 101.3° F [38.5 ° C] or higher) should wait until they recover before getting the vaccine.

How to help patients with shingles

Singles can be extremely painful and debilitating, even decreasing quality of life. By understanding the disease, its treatment, and complications, you can help those who have this illness. To help prevent shingles, teach patients about the shingles vaccine and urge those ages 60 and older to get it.

DeSales Foster is a wound care nurse practitioner at Riddle Memorial Hospital in Media, Pennsylvania.

Selected references

Albrecht MA. Clinical manifestations of varicella-zoster virus infection: herpes zoster. UpToDate, Inc.; 2016.

Bader MS. Herpes zoster: diagnostic, therapeutic, and preventive approaches. Postgrad Med. 2013; 125(5):78-91.

Centers for Disease Control and Prevention. Shingles surveillance. August 19, 2016.

Cohen JI. A new vaccine to prevent herpes zoster. N Engl J Med. 2015;372(22):2149-50.

Cunningham AL, Lal H, Kovac M, et al; ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019-32.

Devi MR, Haribabu Y, Velayudhankutty S, et al. Review on: shingles, its complications & management. Pharma Innov J. 2013;2(4):21-7.

Gilden D, Nagel M, Cohrs R, Mahalingam R, Baird N. Varicella zoster virus in the nervous system. F1000Res. 2015;4:pii.

Harpaz R, Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008;57(RR-5):1-30.

Johnson BH, Palmer L, Gatwood J, et al. Annual incidence rates of herpes zoster among an immunocompetent population in the United States. BMC Infect Dis. 2015;15:502.

Lal H, Cunningham AL, Godeaux O, et al; ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087-96.

Marin M, Yawn BP, Hales CM, et al. Herpes zoster vaccine effectiveness and manifestations of herpes zoster and associated pain by vaccination status. Hum Vaccin Immunother. 2015;11(5):1157-64.

Nagel MA, Gilden D. Neurological complications of varicella zoster virus reactivation. Curr Opin Neurol. 2014;27(3):356-60.

Nagel MA, Gilden D. Update on varicella virus vasculopathy. Curr Infect Dis Rep. 2014;16(6):407.

Oxman MN, Levin MJ, Johnson GR, et al; Shingles Prevention Study Group. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005;352(22):2271-84.

Knowing when to ask for help

As a wound care expert, you’re probably consulted for every eruption, scrape, and opening in a patient’s skin. Occasionally during a patient assessment, you may scratch your head and ask yourself, “What is this? I’ve never seen anything like it.”

Most wound care experts want to help heal everyone, and most of us love a challenge. But when should we step back and consider referring the patient to another clinician?

In a recent conversation, a healthcare clinician told me about the “magic” protocol she uses at the outpatient wound clinic where she works. A patient came to the clinic complaining that the current ostomy skin barrier kept leaking and wouldn’t stay in place longer than 2 days. The clinician started the patient on her protocol, which involves multiple ostomy products, some of them off-label, along with a heating pad to achieve an ostomy skin barrier that stays in place for at least 3 weeks with no change required.

For 3 weeks? Wow! The clinician was so proud she was saving the patient money. But by asking a few questions, I found out that:

the skin barrier manufacturer recommends a maximum 7-day wear time for the product

the clinician learned about the protocol from another clinician, who’d heard about it from a patient

none of the clinicians involved had ostomy management training

the patient now has severe denuded skin around the stoma.

Moral of the story: Even though this clinician had good intentions, she should have referred her patient to an ostomy specialist. She still would have saved her patient money and time and would most likely have prevented the peristomal skin breakdown.

When encountering a skin or wound problem for the first time, we need to look beyond just the local wound bed and complete a holistic, detailed review of the patient’s clinical history, including systemic, local, and psychosocial factors that affect wound healing. If you can’t determine an obvious cause or you lack the knowledge or experience to deal with the patient’s problem, initiate a referral immediately. For wounds on the lower extremities, refer the patient to a vascular surgeon or specialist or to another wound specialist; for a diabetic wound or toenail complications, refer the patient to a diabetic specialist, podiatrist, or another wound specialist; for an unknown rash, skin eruption, or allergic reaction, refer the patient to a dermatologist; and for ostomy or stoma-related problems, refer the patient to an ostomy specialist or surgeon.

Don’t let pride get in the way of doing what’s best for your patients. To paraphrase Karen Marie Moning, author of Dreamfever, Strength isn’t about being able to do everything alone. Strength is knowing when to ask for help and not being too proud to do it.

Donna Sardina, RN, MHA,WCC, CWCMS, DWC, OMS

Editor-in-Chief, Wound Care Advisor

Cofounder, Wound Care Education Institute

Ostomy documentation tips

General characteristics

Document if the diversion is an intestinal or urinary ostomy, whether it’s temporary or permanent, and the location— abdominal quadrant, skin fold, umbilicus. (See Descriptor reference.)

Describe the type of ostomy:

colostomy (colon)—sigmoid or descending colostomy, transverse colostomy, loop colostomy, ascending colostomy

ileostomy (small bowel)—ileoanal reservoir (J-pouch), continent ileostomy (Kock pouch)

urostomy (bladder)—continent urostomy, Indiana pouch, orthotopic neobladder.

Document the presence and location of bowel sounds.

Stoma information

Note the type:

loop (two openings through one stoma)

end (one stoma)

double barrel (two distinct stomas).

Document the overall appearance (shiny, taut, edematous, dry, moist, pale, textured, smooth, bloody) and the presence of stents, rods, drains (include type and location).

Describe the color (red, beefy red, pink, pale pink, purple, blue, black) and shape (round, oval, budded).

Note the height:

flush—at skin level

prolapsed—telescoped out from the abdominal surface.

Document the size in millimeters:

Round stomas are measured by diameter.

Oval stomas are measured by widest length and width.

Describe the lumen:

location—straight up, side, level with skin, or centrally located

number of lumens, stenosis, or stricture.

Note: Document the location of the lumen by using the clock system, with the patient’s head at 12:00.

Describe the odor—presence or absence of odor, strong, foul, pungent, fecal, musty, sweet.

Note whether the stoma and peristomal skin junction is intact or separated.

Effluent

For a fecal stoma, describe the amount, consistency, and overall appearance of effluent— thick, viscous, liquid, pasty, oily, formed, soft, thin, tarry.

For a urinary diversion, describe urine characteristics, volume, presence of odor (musty, fishy, fecal, acid), color (clear, cloudy, amber, straw, colored, blood tinged), and presence of substances other than fluid (grit, crystals, mucous strands).

Peristomal skin

Describe the characteristics of peristomal skin—color, edema, firmness, intactness, induration, pallor, lesions, texture, scar, incision, rash, staining, moisture.

Assess a minimum of 2 inches out from around the stoma.

Appliance and accessories

Document the type of ostomy appliance and accessories. Include the pouching system product, size, and product number. Note the presence of a spout, the convexity, and whether it’s a one-piece or two-piece system,

Observe and document proper function and adhesion, and complications experienced with appliance systems. Document any modifications to the care plan, implementation of new orders, and referrals.

Other important information

Document pain—location, causative factors, intensity, quality, duration, alleviating factors, patterns, variations, interventions.

Note stoma or peristomal skin complications— mucocutaneous separation, stenosis, necrosis, bleeding, dermatitis, folliculitis, peristomal hernia, caput medusae, peristomal hyperplasia, pseudoverrucous lesions, allergic dermatitis, contact dermatitis, pouch leakage, infection.

Document patient and caregiver education— topics covered, level of understanding, and education materials distributed.

Nancy Morgan, cofounder of the Wound Care Education Institute, combines her expertise as a Certified Wound Care Nurse with an extensive background in wound care education and program development as a nurse entrepreneur.

Information in Apple Bites is courtesy of the Wound Care Education Institute (WCEI), © 2016.

Clinician Resources

Here is a round-up of resources that you may find helpful in your practice.

New illustrations for pressure-injury staging

The National Pressure Ulcer Advisory Panel (NPUAP) has released new illustrations of pressure injury stages. You can download the illustrations, which include normal Caucasian and non-Caucasian skin illustrations for reference.

There is no charge for the illustrations as long as they are being used for educational purposes, but donations to support the work of NPUAP are appreciated.

Ostomy self-advocacy resource

Download the most recent version of the ostomy self-advocacy checklist from the United Ostomy Associations of America. This resource for patients with new ostomies details action steps and provides valuable information. The checklist can be customized with the name and contact information for the local ostomy support group.

Lymphedema webinars

Ready to boost your knowledge about lymphedema? Consider watching a free, on-demand webinar from the Lymphatic Education & Research Network’s symposium series.

Sample topics include:

current and emerging surgical approaches in lymphedema

an overview of normal lymphatic anatomy and ultrastructure

genetics and lymphedema.

Delirium resource

Patients with delirium present many challenges for clinicians. You can get help at a special section of the American Nurses Association’s website dedicated to the topic.

The section includes:

statistics about delirium

links to many resources for clinicians and families

delirium primer for nurses.

Clinical Notes, September 2016

Electrical stimulation and pressure ulcer healing in SCI patients

A systematic review of eight clinical trials of 517 patients with spinal cord injury (SCI) and at least one pressure ulcer indicates that electrical stimulation increases the healing rate of pressure ulcers. Wounds with electrodes overlaying the wound bed seem to have faster pressureulcer healing than wounds with electrodes placed on intact skin around the ulcer.

A quantitative, pooled analysis and systematic review of controlled trials on the impact of electrical stimulation settings and placement on pressure ulcer healing rates in persons with spinal cord injuries,” published in Ostomy Wound Managementstates that the overall quality of the studies was “moderate” and that future trials “are warranted.”

Effect of antiseptics on maggot viability

The short-term application of wound antiseptics on wound beds does not impair the viability of maggots, according to a study in International Wound Journal.

Viability of Lucilia sericata maggots after exposure to wound antiseptics” reports that the maggots can survive up to 1 hour of exposure to antiseptics, such as octenidine, povidone-iodine, or polyhexanide.

Global impact of diabetes underestimated

The prevalence of global diabetes has been seriously underestimated by at least 25%, according to a study published in Nature Reviews Endocrinology.

Diabetes mellitus statistics on prevalence and mortality: facts and fallacies” indicates that there may be more than 100 million people with diabetes globally than previously thought.

Axillary evaluation and lymphedema

A retrospective cohort study in Epidemiology reports that women with ductal carcinoma in situ who receive an axillary evaluation have higher rates of lymphedema, without breast cancer-specific or overall survival benefit.

Axillary evaluation and lymphedema in women with ductal carcinoma in situ” included 10,504 women.

Topical insulin and pressure ulcers

A randomized, controlled trial to assess the effect of topical insulin versus normal saline in pressure ulcer healing” concludes that topical insulin is safe and effective in reducing the size of pressure ulcers compared to normal saline-soaked gauze.

Participants of the study, published in Ostomy Wound Management, received either normal saline dressing gauze or insulin dressing twice daily for 7 days. The insulin was sprayed over the wound surface with an insulin syringe, allowed to dry for 15 minutes, and then covered with sterile gauze.

Sexual function and ostomy

Sexual function and health-related quality of life in long-term rectal cancer survivors” reports that long-term sexual dysfunction is common in patients who have undergone surgery for rectal cancer, with more problems seen in patients who have a permanent ostomy.

The study, published in the Journal of Sexual Medicine, included 181 patients with an ostomy and 394 patients with anastomosis.

Effect of venous leg ulcers on body image

Many patients with venous leg ulcers have low self-esteem and negative feelings about their bodies, according to a prospective study published in Advances in Skin & Wound Care.

The impact of venous leg ulcers on body image and self-esteem” included 59 participants. The mean score on the Rosenberg Self-esteem Scale was 22.66, indicating low self-esteem.

Our gold medal issue: Best of the Best 2016

This issue marks the fourth anniversary of the “Best of the Best” issue of Wound Care Advisor, the official journal of the National Alliance of Wound Care and Ostomy. Fittingly, it comes during an Olympics year. Since 1904, the Olympics have awarded gold medals to athletes whose performance makes them the “best of the best.” This year, we’re proud to present our own “Best of the Best” in print format.

Normally, we come to you via the Internet, so this is most likely the first time you’re holding Wound Care Advisor in your hands. Using a digital format for our peer-reviewed journal allows us to bring you practical information you can access anytime, anywhere, as well as the chance to view videos and access links to other valuable resources for you and your patients. But sometimes, it’s nice to hold the print version of a journal. We hope that this annual compilation of our most popular articles will be a resource you can turn to again and again.

If you’re new to Wound Care Advisor, this issue gives you an opportunity to see what you’ve been missing. If you’re a regular reader, it lets you revisit some of our best articles. We’ve selected articles our readers have awarded “gold medals” by viewing them frequently online.

Within these pages, you’ll find feature articles, best practices, step-by-step procedures, clinical resources, and news. Along with wound-related topics—including pediatric pressure ulcers, medications and wound healing, epibole, and support surfaces—you can read up on other topics, including peristomal skin problems, skin tears, and cutaneous candidiasis.

This special issue also includes the 2016 Wild on Wounds Exhibitors Guide. Wild on Wounds (WOW) is an annual multidisciplinary national wound conference presented by the Wound Care Education Institute. The exhibitors guide features names, products, and contact information for manufacturers and companies that offer solutions to help you care for your patients. The guide is also available digitally on our website, woundcareadvisor.com, where can you download resources and access links to instructional and informational videos, clinical resources, and much more.

We appreciate your support and look forward to bringing you many more articles designed to help you “go for the gold” in your clinical practice.

SardinaSignature

Donna Sardina, RN, MHA, WCC, CWCMS, DWC, OMS

Editor-in-Chief

Wound Care Advisor

Lymphedema and lipedema: What every wound care clinician should know

Imagine you have a health condition that affects your life every day. Then imagine being told nothing can be done about it; you’ll just have to live with it. Or worse yet, your physician tells you the problem is “you’re just fat.”

Many people with lymphedema or lipedema have no idea their condition has a name or that many other people suffer from the same thing. Although lymphedema and lipedema can’t be cured, proper management and resources can help patients cope. This article improves your grasp of these conditions, describes how to recognize and manage them, and explains how to support your patients.

To understand lymphedema and lipedema, first you need to understand how the lymphatic system functions. It makes lymph, then moves it from tissues to the bloodstream. It also plays a major role in the immune system, aiding immune defense. In addition, it helps maintain normal fluid balance by promoting fluid movement from the interstitial tissues back to the venous circulation. (See Lymphatic system: Four major functions.)

If the lymphatic system is impaired from a primary (hereditary or congenital) condition or a secondary problem, lymphedema can result. In this chronic, potentially progressive, and incurable condition, protein-rich fluid accumulates in the interstitial tissues.

Lymphedema basics

Lymphedema occurs in four stages.

Stage 0. During this stage (also called the subclinical or latency stage), transport capacity of the lymphatic system decreases but remains sufficient to manage normal lymphatic loads. Signs and symptomsaren’t evident and can be measured only by sensitive instruments, such as bioimpedance spectroscopy and optoelectronic volumetry. Without such instruments to quantify volume changes, diagnosis may rest on subjective complaints.

In this stage, limited functional reserve of the lymphatic system leads to a fragile balance between subnormal transport capacity and lymphatic loads. Added stress on the lymphatic system (as from extended heat or cold exposure, injury, or infection) may cause progression to stage 1.

Providing appropriate patient information and education, especially after surgery, can dramatically reduce the risk that lymphedema will progress to a more serious stage.

Stage 1. Considered the spontaneously reversible stage, stage 1 is marked by softtissue pliability without fibrotic changes. Pitting can be induced easily. In early stage 1, limb swelling may recede over – night. With proper management, the patient can expect the extremity to decrease to a normal size compared to that of the uninvolved limb. Otherwise, lymphedema is likely to progress to stage 2.

Stage 1 lymphedema may be hard to distinguish from edemas from other causes. Clinicians must rely on the patient history and monitor for swelling resolution with conventional management, such as compression and elevation, or note if swelling persists despite these standard interventions.

Stage 2. Sometimes called the spontaneously irreversible stage, stage 2 is identified mainly from tissue proliferation and subsequent fibrosis (called lymphostatic fibrosis). The fluid component can be removed spontaneously, but removal of the increased tissue proliferation (initially irreversible) takes more time. Tissue proliferation stems from long-standing accumulation of protein-rich fluid; over time, the tissue hardens and pitting is hard to induce. In many cases, swelling volume increases, exacerbating the already compromised local immune defense.

Consequently, infections (particularly cellulitis) are common; these, in turn, increase the volume of the affected area. Proper treatment can reduce volume.

With proper care (complete decongestive therapy [CDT]), lymphedema can stabilize during stage 2. But patients with chronic or recurrent infections are likely to progress to stage 3.

Stage 3. Also called lymphostatic elephantiasis, this stage is marked by further fluid volume increases and progression of tissue changes. Lymphostatic fibrosis becomes firmer and other skin alterations may occur, including papillomas, cysts, fistulas, hyperkeratosis, fungal infections, and ulcers. Pitting may be present. Natural skinfolds deepen (especially those of the dorsum of the wrist or ankle) and, in many cases, cellulitis recurs.

If lymphedema management starts during this stage, reduction can still occur. Even in extreme cases, with proper care and patient adherence to treatment, lymphostatic elephantiasis can be reduced so the leg is a normal or near-normal size.

Assessment and diagnosis

A thorough physical examination is the gold standard for diagnosing lymphedema. A complete patient history, body-systems review, inspection, and palpation can help determine if edema is lymphedema.

Clinically, the only test with proven reliability and validity in diagnosing lymphedema is the Stemmer sign. Fibrotic changes associated with lymphedema can lead to thickened skin over the proximal phalanges of the toes or fingers. If you can’t tent or pinch the skin on the involved extremity, lymphedema is present (a positive Stemmer sign). However, a negative finding (soft, pliable tissue) doesn’t rule out  lymphedema because the condition may be in an early stage, before tissue proliferation and fibrosis have set in.

Management

Although incurable, lymphedema can be managed successfully through CDT. This approach involves proper identification of lymphedema, manual lymph drainage, skin and nail care, patient education, compression, and exercise.

CDT has two phases:

Phase I, the intensive phase, continues until the extremity has decongested or reached a plateau. The clinician provides treatments and educates the patient about all aspects of CDT to prepare him or her for phase II. Phase I can last several weeks to several months depending on lymphedema severity.

Phase II, the maintenance phase, begins once the extremity has decongested or plateaued. This phase still focuses on CDT, but now the patient, not the clinician, is responsible for all care. The goal is to reduce limb size while enabling the patient to become self-sufficient in managing lymphedema. Although CDT can bring significant improvements in limb size, skin quality, and function, patients must remember that phase II continues lifelong. Be sure to provide education about ongoing self-management strategies.

Lipedema: The disease they call “fat”

Lipedema is a painful disorder of fat deposition. Pathologic deposition of fatty tissue (usually below the waist) leads to progressive leg enlargement. Like lymphedema, lipedema is incurable but manageable. Unless managed properly, lipedema can reduce mobility, interfere with activities of daily living, and lead to secondary lymphedema. (See Lipedema stages.)

Lipedema commonly is misdiagnosed as lymphedema. However, lymphedema involves protein-rich fluid, whereas lip edema is a genetically mediated fat disorder. Because lipedema resists diet and exercise, it can lead to psychosocial complications. Lipedema occurs almost exclusively in women; typically, onset occurs between puberty and age 30. One unpublished epidemiologic study puts lip edema incidence in females at 11%. Some patients have a combination of lipedema and lymphedema. (See Viewing lipolymphedema.)

Assessment and diagnosis

As with lymphedema, lipedema diagnosis rests on clinical presentation. Lipedema characteristics include bilateral and symmetrical involvement, absence of pitting (because lipedema isn’t a fluid disorder), soft and pliable skin, and filling of the retromalleolar sulcus (called the fat pad sign.)

Key signs and symptoms include:

• feeling of heaviness in the legs (aching dysesthesia)

• easy bruising

• sensitivity to touch (called “painful fat syndrome”)

• orthostatic edema

• oatmeal-like changes to skin texture.

Nearly half of lipedema patients are overweight or obese, but many appear of normal weight from the waist up. Essentially, the upper and lower extremities don’t match. The lower extremities typically show fatty deposits extending from the iliac crest to the ankles, sparing the feet. (See Lipedema patterns.)

Management

Lipedema is best  managed through weight control, as additional weight gain through adipose tissue tends to deposit in the legs. For patients with concomitant lymphedema (lipolymphedema), modified CDT helps reduce and manage lymphatic compromise. To address excess fat deposition, newer “wet” liposuction techniques have proven beneficial. These techniques gently detach adipose cells from the tissue, helping to preserve connective tissue and lymphatic vessels.

Know what to look for

In both lymphedema and lipedema, early identification and proper diagnosis are key. (See Differentiating lymphedema and lipedema.) A thorough history and physical exam will likely lead to an accurate diagnosis, if clinicians know what to look for. Proper diagnosis and treatment can prevent expensive and ineffective interventions, which can negatively affect both the patient’s condition and psychological well being.

Heather Hettrick is an associate professor at Nova Southeastern University, Department of Physical Therapy in Fort Lauderdale, Florida.

Selected references

Fat Disorders Research Society. Lipedema description.

Fife CE, Maus EA, Carter MJ. Lipedema: a frequently misdiagnosed and misunderstood fatty deposition syndrome. Adv Skin Wound Care. 2010;23(2):81-92

Herbst KL. Rare adipose disorders (RADS) masquerading as obesity. Acta Pharmacol Sin. 2012;33(2):155-72.

Lipedema Project.

National Lymphedema Network. Position papers.

Schmeller W, Hueppe M, Meier-Vollrath I. Tumescent liposuction in lipoedema yields good long-term results. Br J Dermatol. 2012;166(1):161-8.

Zuther J. A closer look at lipedema and the effects on the lymphatic system. December 13, 2012. lymphedemablog.com/2012/12/13/a-closer-look-at-lipedema-and-the-effects-on-the-lymphatic-system/

Zuther J. Stages of lymphedema. October 3, 2012.

Practicing emotional intelligence may help reduce lateral violence

It’s been a stressful day at work—nothing new. One confused patient pulled off her ostomy bag, you’re having difficulties applying negative-pressure wound therapy on another, and a third patient’s family is

angry with you. We all experience stressful days, but unfortunately, sometimes we take our stress out on each other. Too often, this ineffective way of identifying and managing stress leads nurses to engage in lateral violence.

Lateral violence is identified and described by the American Nurses Association as acts between colleagues that include covert or overt aggression. These acts of displaced stress can create a tense work environment and psychological anguish, and may even lead some clinicians to quit their jobs or abandon their profession all together. The unnecessary outcomes of lateral violence require that we, as professionals, proactively seek out meaningful methods to identify and reduce its formation and occurrence. The first step in this endeavor is to examine and develop our emotional intelligence (EI).

What is EI?

EI is the ability to understand and control our own emotions while reading and adjusting to the emotions of others. The behaviors and traits of people who have high EI levels are also those of people who are less likely to engage in lateral violence. There are other benefits, too. For example, a study conducted with ICU nurses demonstrated that EI education increased nurses’ general health.

Improving EI skills

A study by Sharif and colleagues reported that EI can be taught, meaning we all have the potential to increase our self-awareness, self-regulation, and empathy. Strengthening these aspects of EI can help us to not only understand ourselves, but also how our emotions impact our colleagues.

The first step is to educate ourselves about EI. Next, we must adapt our daily culture to incorporate EI into our practice. Clinicians are, after all, nothing if not adaptable. We have gone from paper charting to electronic charting, from wet-to- dry dressings to better wound care options, and from provider-centered interventions to patient-centered, evidence-based practice.

This adaptation requires the use of three tools: purposeful reflection, improvisation, and empathy.

Purposeful reflection

Self-awareness occurs when we engage in purposeful reflection, viewing a situation from multiple angles with the intent to learn and improve decision making. Take a moment to think about a recent situation when an interaction or conversation did not go well. What started it? What were you feeling at the time? Did you have a long day at work? Did you expect this person to say something you didn’t want to hear? Did someone approach you and demand an immediate conversation?

Now remove yourself from that moment and think of yourself as another person looking in. If you removed the emotions, what was that conversation truly about? Was fear involved? Were you put in a situation that should have been handled at another time? Reflecting purposefully on the situation enables you to recognize the irrational responses.

Purposeful reflection also enables you to identify negative patterns, called triggers. Learning to recognize triggers may prevent unfavorable situations or reactions. Purposeful reflection, when done consistently, will aid in reducing negative energy, cut short the conflict, and possibly prevent tense situations. Once you make purposeful reflection a habit, you can then use improvisation to process conflicts on the spot and provide thoughtful feedback.

Improvisational skills

Applying improvisation skills can help us to control our emotions and can teach us to notice the difference between reactive words and thoughtful words. Here are the steps of improvisation in a situation:

1. Be present in the conversation. This can be achieved by counting to 10 before speaking. Counting to 10 releases the limbic system of the body from the flight or fight emotion, so we can be more thoughtful.

2. Listen to the other person in the situation.

3. Eliminate bias and establish an objective or overall goal for the situation. For example, in nursing we may need to stop thinking how the situation affects us and think about how it affects the patient.

4. Be encouraging even if you don’t agree with someone. Try to find a positive spin on another person’s view before sharing your own opinions.

5. Seek to provide the necessary feedback that will allow the other person to walk away knowing they were heard, whether or not an agreement was made.

Once you’ve honed the tools of purposeful reflection and improvisation, you can develop a stronger sense of empathy.

Empathy

Empathy, the process of walking in another’s shoes, moves us away from focusing on ourselves and towards thinking about the needs of others. It is a fundamental aspect of social interaction. As nurses, we consistently do this with our patients, but rarely do it with our coworkers. If the previous shift’s staff caused a problem that you want to discuss with them, you must protect yourself from letting your emotions become reactive and ask yourself, “Why am I so angry?” Empathy begins with listening. Begin to discuss the situation with the nurse from the last shift by asking an open-ended question. For example say, “How was your night?” Then listen: Your coworker may share that he or she had a significant problem on the shift. Follow through with the conversation to better understand why this coworker was unable to complete a task or complete a task correctly. Do not listen to solve a problem or to think about how this affects you, but rather listen with an open mind as it may present an opportunity to learn or an opening to pose clarifying questions.

An agent of change

By developing and sharing the tools of EI—purposeful reflection, improvisation, and empathy—you can be an agent of change. Being a leader has many challenges, but when others see how calmly you manage yourself, aggressive coworkers, and tense situations, they will be inspired.

Tara Slagle is a course mentor for Western Governor’s University in Salt Lake City, Utah, and a clinical educator at Hanover Hospital in Hanover, Pennsylvania.

Selected references

American Nurses Association. Bullying and workplace violence. 2015.

Caldwell L, Grobbel C. The importance of reflective practice in nursing. Int J Caring Sci. 2013;6(3):319-26.

Martos M, Lopez-Zafra E, Pulido-Martos M, et al. Are emotional intelligent workers also more empathic? Scand J Psychol. 2013;54(5):407-14.

Sharif F, Rezaie S, Keshavarzi S, et al. Teaching emotional intelligence to intensive care unit nurses and their general health: a randomized clinical trial. Int J Occup Environ Med. 2013;4(3):141-8.