Clinical Notes

2012 guideline for diabetic foot infections released

Foot infections in patients with diabetes usually start in a wound, most often a neuropathic ulceration. So clinicians can better manage diabetic foot infections, the Infectious Diseases Society of America (IDSA) published “2012 Infectious Diseases Society of America Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections” in the June 15 Clinical Infectious Diseases.

The guideline updates IDSA’s 2004 diabetic foot infections guideline. It focuses on appropriate therapy, including debridement of dead tissue, appropriate antibiotic therapy, removing pressure on the wound, and assessing (and potentially improving) blood flow to the foot. The guideline also provides suggestions regarding when and how long antibiotics should be administered for soft-tissue and bone infections.

When diagnosing a diabetic patient with foot infection, the guideline recommends clinicians evaluate the patient at three levels—the patient as a whole, the affected foot or limb, and the infected wound. The guideline also provides advice on when and how to culture diabetic foot wounds.

Access a podcast on the guideline, which is available in a smartphone format and as a pocket-size quick-reference edition.

Combining bariatric surgery with medical therapy improves glycemic control

In obese patients with uncontrolled type 2 diabetes, bariatric surgery and 12 months of medical therapy significantly improved glycemic control compared to those who received only medical therapy, according to a study in The New England Journal of Medicine. “Bariatric surgery versus intensive medical therapy in obese patients with diabetes” was a randomized, nonblinded, single-center trial that included 150 patients in three groups: medical therapy only, medical therapy and Roux-en-Y gastric bypass, and medical therapy and sleeve gastrectomy.

Although glycemic control improved for all three groups, those who received bariatric surgery had better control. Use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. No deaths or life-threatening complications occurred.

HHS launches web-based tool for tracking healthcare performance

The U.S. Department of Health and Human Services (HHS) has launched a web-based tool for monitoring the performance of the healthcare system. The Health System Measurement Project gives providers and the public the ability to examine datasets from across the federal government that span specific topic areas, such as access to care, vulnerable populations, prevention, and quality. Users can also view indicators by population characteristics, such as age, sex, income level, insurance coverage, and geography.

PEG tubes may increase risk of new pressure ulcers

According to a study published in Archives of Internal Medicine, percutaneous endoscopic gastrostomy (PEG) tubes may increase the risk of pressure ulcers in nursing home patients with advanced cognitive impairment.

Researchers found that hospitalized patients who receive a PEG tube were 2.27 times more likely to develop a new pressure ulcer and those with a pressure ulcer were less likely to have it heal when they had a PEG tube. “Our findings regarding the risk of developing new stage 2 or higher pressure ulcers suggest that PEG feeding tubes are not beneficial, but in fact they may potentially harm patients,” conclude the researchers in “Feeding tubes and the prevention or healing of pressure ulcers.”

AHRQ provides QI toolkit for hospitals

The Agency for Healthcare Research and Quality (AHRQ) offers a toolkit designed to help hospitals understand AHRQ’s quality indicators (QIs). “AHRQ Quality Indicators™ Toolkit for Hospitals” includes steps for improvement, how to sustain change, and different tools for different audiences. Clinicians can also access audio interviews that provide information on how to use the tools and engage stakeholders and staff in QI efforts, and a recording of a webinar on the toolkit.

Silk fibers may be future resource for bone and tissue repair

Researchers at Tufts University have developed the first all-polymeric bone scaffold material that is fully biodegradable and capable of providing significant mechanical support during repair. The material could improve the way bones and tissues are repaired after an accident or following disease effects.

The new technology uses micron-size silk fibers to reinforce a silk matrix, much as steel rebar reinforces concrete. The study, “High-strength silk protein scaffolds for bone repair,” published in Proceedings of the National Academy of Sciences, found that the scaffold material is significantly less strong than normal bone, but it may play a role as a temporary biodegradable support for the patient’s cells to grow.

International guidelines for silver dressings in wounds released

June’s Wounds International includes “International consensus: Appropriate use of silver dressings in wounds.”

A meeting of an international group of experts, convened by Wounds International, met in December 2011 to compile the consensus guidelines, which describe the patients who are most likely to benefit from silver dressings and how to use the dressings appropriately.

The guidelines recommend that silver dressings be used “in the context of accepted standard wound care for infected wounds or wounds that are at high risk of infection or reinfection.” Another recommendation is to use silver dressings for 2 weeks, then evaluate the wound, patient, and management approach before deciding whether to continue using the dressing or if a more aggressive intervention such as antibiotics would be better.

Cell therapy may benefit patients with lower extremity CLI

Injections of ixmyelocel-T in patients with lower extremity critical limb ischemia (CLI) who aren’t candidates for revascularization can prolong the time until treatment failure, according to a study in Molecular Therapy. Time to treatment failure was defined as major amputation, all-cause mortality, doubling of total wound surface area from baseline, or de novo gangrene. The double-blind, placebo-controlled RESTORE-CLI trial found that the adverse event rates were similar in the two groups.

New skin patch destroys skin cancer cells

A new skin patch destroyed facial basal cell carcinoma cells in 80% of patients, according to a study reported at the Society of Nuclear Medicine’s 2012 Annual Meeting.

Each of the 10 patients with facial basal cell carcinoma received a custom-made and fully sealed phosphorus-32 skin patch, a radiation spot-treatment in the form of a patch. Each patient was treated for 3 hours on the first day; the patches were reapplied on the fourth and seventh days after the first treatment for another 3 hours each. Three years after treatment, 8 of 10 patients were cancer-free.

The patients had lesions near the eyes, the nose, and forehead—areas more difficult to operate on, especially if skin grafting is needed later.

Small study links lymphedema to obesity

The average body-mass index (BMI) in obese patients with lymphedema was significantly greater than BMIs of obese patients without lymphedema, according to correspondence in The New England Journal of Medicine. The authors conclude, “Our findings suggest that obesity…may be a cause of lower-extremity lymphedema.”

Lower-Extremity Lymphedema and Elevated Body-Mass Index” included 15 obese patients with bilateral lower-extremity enlargement who were referred to the authors’ center. Of the 15, five were diagnosed with lymphedema by lymphoscintigraphy.

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“But I left voice messages and a note…”

By Nancy J. Brent, MS, RN, JD

Often nurses get named in a lawsuit when they are involved in clearly negligent conduct that causes an injury to or the death of a patient. Examples include administering the wrong medication to the wrong patient or not positioning a patient correctly in the operative suite prior to surgery. Sometimes, however, the negligent behavior of a nurse is not as clear to the nurse involved in the care of the patient.
That was apparently the circumstance in the reported case, Olsten Health Services, Inc v. Cody.¹ In September 2000, Mr. Cody was the victim of a crime that resulted in paraplegia. He was admitted to a rehabilitation center and discharged on November 15, 2000. His physician ordered daily home health care services in order to monitor his “almost healed” Stage 2 pressure ulcer.² The home health care agency assigned a registered nurse (RN) to Mr. Cody and, after Mr. Cody’s healthcare insurance company would not approve daily visits, a reduced visit plan was approved by Mr. Cody’s physician.

A progressive problem

On November 16, 2000, the nurse visited Mr. Cody for the first time. During that visit, she did an admission assessment and noted that the pressure ulcer, located at the area
of the tailbone, measured 5 cm by 0.4 cm wide and 0.2 cm deep. She believed the pressure ulcer could be completely healed within 3 weeks. The nurse called Mr. Cody’s physician and left him a voice message concerning her visit and her findings.
On November 19, a second visit took place and the nurse observed and documented that Mr. Cody’s pressure ulcer was “100%” pink and no odor was detected.
On November 20, she attempted another visit but did not see Mr. Cody because the front gate surrounding his home was locked. The nurse buzzed the gate doorbell several times to no avail. She left a note on the front gate for the Cody family and left a voice message for Mr. Cody’s physician.

The next visit took place on November 21. The pressure ulcer was now only “90% pink” and had a “fetid” odor; this condition did not improve over the next 24 hours. The nurse documented this fact in her nurses’ notes. Again, she left a voice mail message for the physician concerning these findings.

The nurse could not get into the house on November 23, the next scheduled visit, so she again left a note on the house gate and left a voice mail message for the physician.
On November 24, the home health care nurse saw Mr. Cody and observed the pressure ulcer to be “90% pink” but the “fetid” odor was still present. In addition, Mr. Cody’s right lower extremity was swollen. She was concerned that the wound care that was to be done by the family or the health aide was not being done. Even so, she did not contact Mr. Cody’s physician or the patient again until November 27.

Mr. Cody’s pressure ulcer on November 27 had no odor but the home health aide who was also caring for Mr. Cody told the nurse that he was “very cold and having chills.” The nurse did not document this reported observation in her nurses’ notes.
Attempts to visit Mr. Cody on November 28 and 29 were again unsuccessful because of the locked gate at the front of the house. No one answered the buzzer, either. The nurse left another note on the house gate and left a voice mail message for the physician.

When the nurse saw Mr. Cody on November 30, she observed that the ulcer had “serious changes”: an increase in the serous drainage from the wound; the wound had a “fetid” odor; 80% of the wound was necrotic; the necrotic tissue was “undermined”; and the wound was significantly larger—9 cm by 8 cm wide and 1 cm deep.3 She left a voice mail message for Mr. Cody’s physician, but did not alter her visits to Mr. Cody’s home or attempt to see him over the next 2 days.

Admission to hospital

When the nurse did visit Mr. Cody on December 1, the pressure ulcer consisted of 40% necrotic tissue. She then told the family to take Mr. Cody to the physician’s office. Later that same day he was admitted to the hospital with a Stage 4 pressure ulcer that reached his tailbone. After 3 weeks of treatment, the ulcer measured 20 cm by 30 cm.

Mr. Cody endured many procedures during the following years to treat his
ulcer, but it never really healed. A “flap” enclosure was done to try to cover the wound.

Lawsuit

Mr. Cody sued the home health care company, alleging that the employees breached the standard of care by failing to appropriately diagnose and treat/or to prevent the formation or aggravation of pressure ulcers, resulting in severe and significant injury to him.

Verdict

The Florida Court of Appeals affirmed the trial court’s verdict in favor of Mr. Cody—a $3,050,000 verdict in economic damages4—on several legal bases, the most important for the purposes of this article being that the home health care agency and its employees were negligent in the care of Mr. Cody.

Key testimony

Key testimony in reaching this verdict came from the expert testimony of an RN and certified wound care expert. The nurse expert testified unequivocally that the home health care nurse breached the standard of nursing care. She said that not contacting the physician personally about Mr. Cody’s condition and the family being overwhelmed about his condition, but instead leaving voice mail messages on an answering machine, did not meet the standard of nursing care in this situation.
Additionally, the nurse expert testified that the nurse caring for Mr. Cody failed to recognize the symptoms of his deteriorating condition and did not intervene when necessary to avoid the infection he suffered from the deteriorating wound, and that her failure to do so resulted in the development of the Stage 4 ulcer that never healed.

Take-away points

So, what does this case tell you as a wound care professional caring for someone who has a pressure ulcer?

  • Meet the standard of care. You must always meet the standard of care when caring for a patient. That means your care must be what other ordinary, reasonable, and prudent nurses caring for a patient with a decubitus ulcer would do in the same or similar circumstances in the same or similar community. Clearly, the nurse did not meet this standard in her care of Mr. Cody.
  • Document accurately and completely. Remember that the nurse did not document Mr. Cody’s condition when the home health aide reported it to her. This omission may not only have compromised Mr. Cody’s care. If the communication during the trial became an “I told her”/”I don’t remember being told” debate when each party testified about the communication, it surely caused a rift between the aide and the nurse during the trial proceedings. Such a disagreement between defendant employees always helps a plaintiff’s case.
  • Know that photographs can be used in court. This case used a specific form of evidence, demonstrative evidence: photographs taken of the pressure ulcer, which were admitted into evidence during the trial. The photographs were testified to by the wound care expert. In addition to her testimony, this evidence further showed the “natural and continual progression” of the ulcer as it existed on December 1, 2000.
  • Understand the importance of expert testimony. In professional negligence cases, expert testimony is essential to establish the standard of care and to provide an opinion as to whether the standard of care was met or breached, the breach of which led to the injury to the patient. Typically, the attorney of a nurse cited in this type of case would want to use a certified wound care expert to support the care given. Apparently, the home care agency’s expert witness was not as convincing as the expert witness’s testimony for Mr. Cody.

Indeed, in this case, the expert witness’s testimony was invaluable and essentially secured a verdict for the plaintiff. Not only was the expert witness board certified but her testimony was credible, based on the evidence presented, and given after a careful review of Mr. Cody’s medical records, admission and discharge summaries from hospitals and health centers that provided care to Mr. Cody, the depositions of several doctors and nurses, and Mr. Cody’s deposition.

  • Know your limits. The nurse’s conduct also stresses the importance of another legal principle—knowing the limits of your abilities and capabilities. Nowhere in the reported opinion are the RN’s qualifications listed or a reason given as to why she was selected to care for Mr. Cody. It is assumed she was not certified. Even basic nursing guidelines for wound care and communication to the physician were not followed. Why, then, did she agree to take this assignment? She did so not only at her own folly but to the detriment of Mr. Cody.
  • Protect your patient. Last, and by no means least, this case stands for the principle that if you simply document something in the patient’s record that
    is important regarding the patient’s well-being and you just leave voice mail messages for a physician about that “something,” such conduct is not adequate. By simply leaving messages and notes, this RN violated an age-old principle in the law of professional negligence.5

Your duty in any situation in which the patient is at risk for a foreseeable and unreasonable risk of harm is to prevent that harm from happening insofar as humanly possible. What those specific steps might be will depend on the circumstances and your patient’s condition. Remember, liability is always fact-specific. Although legal principles exist, how each applies to a particular situation may vary.

Mr. Cody was clearly at risk for a foreseeable and unreasonable risk of harm—the further deterioration of his pressure ulcer. The nurse would only have had to intervene sooner by, for example (and as testified to by the expert witness), personally talking with his physician, visiting the patient more frequently when the deterioration began, contacting social services to help the family with its “overwhelmed” feelings, and following up with the home health aide’s observations of Mr. Cody.

Think about this, too: Nowhere in the court of appeals’ record was it indicated that Mr. Cody’s family or the physician ever received the notes or voice mail messages left by the nurse.6 At a minimum, wouldn’t you as the nurse want to follow up and check if those communications had been received?

References
1. Olsten Health Services, Inc. v. Cody, 979 So. 2d 1221 (FL District Ct of Appeals) 2008. (pages 1-8). http://caselaw.findlaw.com/fl-district-court-of-appeal/1160380.html. Accessed June 22, 2012.

2. Id. at 1.

3. Id. at 4.

4. Id. at 2. The doctrine of comparative negligence was used in this case. This doctrine, adopted by most states, reduces a plaintiff’s recovery of money proportionally to the plaintiff’s degree of fault in causing the injury that is the basis of the suit (Blacks Law Dictionary, Second Pocket Edition, Bryan Garner, ed. St. Paul, MN: West; 2001). In this case, the home health care agency’s fault was attributed to be 70%. Mr. Cody’s degree of fault was assessed by the jury at 30%, most probably due to the inability of the home care nurse to be given access into the house on the days she visited and the family not providing the wound care required by Mr. Cody’s decubitus ulcer.

5. This age-old principle was established in a 1965 Illinois case, Darling v. Charleston Community Hospital, 211 N.E. 2d 353 (IL Supreme CT) 1965.

6. Tammelleo D. Treatment of decubitus ulcers botched: verdict for $3,050,000. Nurs Law Regan Rep. 2008;49(1):1.

Nancy J. Brent is an attorney in Wilmette, Illinois. The information in this article is for educational purposes only and does not constitute legal advice.

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Wound Healing Improves With New Bioactive Peptide Combo

bioactive peptide

By combining bioactive peptides, researchers have successfully stimulated wound healing in an in vitro and in vivo study. The studies, published in PLoS ONE, show that the combination of two peptides stimulates growth of blood vessels and promotes tissue re-growth of tissue. Further research into these peptides could potentially lead to new therapies for chronic and acute wounds.

The researchers evaluated a newly-created peptide, UN3, in pre-clinical models with the goal of simulating impaired wound healing as in patients suffering from peripheral vascular diseases or uncontrolled diabetes. They discovered that the peptide increased the development of blood vessel walls by 50%, with an 250% increase in blood vessel growth, and a 300% increase in cell migration in response to the injury. (more…)

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