Clinical Assessment of a Biofilm-Disrupting Agent for the Management of Chronic Wounds Compared With Standard of Care

A Therapeutic Approach

Daniel Kim, MD; William Namen II, DPM; January Moore, BA; Mauricia Buchanan, BSN; Valerie Hayes, PhD; Matthew F. Myntti, PhD; Albert Hakaim, MD

Disclosures

Wounds. 2018;30(5):120-130. 

In This Article

Limitations

The greatest challenges for patients with chronic wounds involve getting the patient to adhere to dressing changes and weekly standard of care visits for surgical wound debridements.[34,35] This was also a study limitation as patient wounds were clinically assessed at weeks 0, 2, 4, 8, 12, and 16, and patient compliance with the daily dressing and proper daily application of the wound gel was gauged by patient report alone. However, results show the wound reduction rate increased as the treatment time progressed, indicating that those wounds that were not yet closed were progressing towards closure despite the visit interval and compliance limiting factors. This may be explained by the mechanism of action and properties of the experimental product. Preclinical testing has shown biofilm bacterial load is reduced by 3.5 log to 8 log within 24 hours, and planktonic bacteria is reduced by 4 log to 7 log in 60 minutes in in vitro measurements; its residence time in the wound is measured up to 2 days following application.[8,17]

Another limitation was that the patient populations between the experimental group and the control group were not matched with regards to their comorbidities. Statistically, the experimental and control groups were equivalent for the number of patients with diabetes and hypertension. There were statistically significantly higher percentages of patients with peripheral arterial disease and classified as overweight in the experimental group than in the control, indicating that the experimental product was presented with a more challenging group to treat.

Confounding factors encountered during this study included prescribed wound treatments other than the experimental or control agent, such as becaplermin, skin grafts, and antibiotics, which rendered data invalid after that point. However, as the wound size decreases and they start to progress anew through the healing stages, using skin grafts and other debridement products is part of the multiple approaches the practitioner may use to further accelerate wound closure. Although specific concomitant treatments were confounding factors that would impair interpretation of the data analysis, previous study results[8] have shown that combining antimicrobial and the experimental agents have a synergistic effect on chronic wounds.

In the future, efficacy of the wound gel in specific types of chronic wounds, such as those caused by diabetes and venous insufficiency, should be investigated. In addition, further investigation of various standard of care protocols versus the experimental product is warranted, as well as those protocols in combination with the biofilm-disrupting agent. Finally, this experimental product's role in the prevention of chronic wounds should be investigated and could be tested in postoperative and burn treatment settings.

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