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Advances in Skin & Wound Care:
doi: 10.1097/01.ASW.0000394027.82702.16
Features: Original Investigation

Reduction of Bacterial Burden and Pain in Chronic Wounds Using a New Polyhexamethylene Biguanide Antimicrobial Foam Dressing-Clinical Trial Results

Sibbald, R. Gary BSc, MD, MEd, FRCPC (Med Derm), MACP, FAAD, MAPWCA; Coutts, Patricia RN, IIWCC; Woo, Kevin Y. PhD, RN, ACNP, GNC(C), FAPWCA

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Abstract

OBJECTIVE: A randomized controlled trial to evaluate the effectiveness of a polyhexamethylene biguanide (PHMB) foam dressing compared with a similar non-antimicrobial foam for the treatment of superficial bacterial burden, wound-associated pain, and reduction in wound size.

SETTING AND PARTICIPANTS: This study was conducted in 2 wound healing clinics-a university hospital-based clinic and a community-based clinic. Forty-five chronic wound subjects, stratified to either foot or leg ulcers, were followed for 5 weeks.

METHODS: A multicenter, prospective, double-blind, pilot, randomized controlled clinical trial with 3 study visits (Weeks 0, 2, 4) documented pain and local wound characteristics using NERDS and STONEES clinical criteria to determine superficial bacterial damage or deep/surrounding infection.

RESULTS: The use of PHMB foam dressing was a significant predictor of reduced wound superficial bacterial burden (P = .016) at week 4 as compared with the foam alone. Pain reduction was also statistically significant at week 2 (P = .0006) and at week 4 (P = .02) in favor of the PHMB foam dressings. Polymicrobial organisms were recovered at week 4 in 5.3% in the PHMB foam dressing group versus 33% in the control group (P = .04). Subjects randomized to the PHMB foam dressing had a 35% median reduction in wound size by week 4, compared with 28% in the control group.

CONCLUSIONS: PHMB foam dressing successfully reduced chronic wound pain and bacterial burden.

© 2011 Lippincott Williams & Wilkins, Inc.

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