Clinical assessment of a biofilm-disrupting agent for the management of chronic wounds compared with standard of care: A therapeutic approach

Daniel Kim, William Namen, January Moore, Mauricia Buchanan, Valerie Hayes, Matthew F. Myntti, Albert Hakaim

Research output: Contribution to journalArticle

5 Scopus citations

Abstract

Objective. The authors study the use of a biofilm-disrupting wound gel designed for wound management to determine if disrupting chronic wound biofilm would be therapeutically efficacious. Materials and Methods. This prospective, randomized, open-label clinical trial was performed from September 2014 through March 2016. Forty-three patients (22 experimental, 21 control) with chronic, recalcitrant wounds were randomized to a 12-week treatment with a biofilm-disrupting wound gel (experimental) or a broad-spectrum antimicrobial ointment (control). The wound healing rate was assessed by measuring wound size reduction and wound closure rates. Results. Wound size in the experimental group decreased significantly with a 71% reduction in wound area compared with 24% for the control (P < .001). Wound closure was attained in more than half of the patients (14) treated with the experimental product. Fifty-two percent of these patients achieved closure by 12 weeks as opposed to 17% for the control (P < .01). No adverse events related to the experimental product were recorded, but 2 adverse reactions occurred with the control. Conclusions. The combination of the experimental product and wound debridement significantly improved wound healing rates by disrupting the biofilm, which protects multispecies bacteria within a chronic wound. Given the significant wound size reduction and closure rates observed in these long-term, nonhealing wounds, as well as the lack of related serious adverse events, the investigators believe the biofilm-disrupting wound gel to be a safe and effective treatment for recalcitrant chronic wounds.

Original languageEnglish (US)
Pages (from-to)120-130
Number of pages11
JournalWounds
Volume30
Issue number5
StatePublished - May 1 2018

Keywords

  • Antimicrobial resistance
  • Biofilm
  • Chronic wound
  • Diabetic foot ulcer
  • Extracellular matrix
  • Infection

ASJC Scopus subject areas

  • Surgery
  • Medical–Surgical

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