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.
This study compares the clinical performance of a polyhexamethylene biguanide-impregnated foam dressing with a similar non-antimicrobial foam dressing.
R. Gary Sibbald, BSc, MD, MEd, FRCPC (Med Derm), MACP, FAAD, MAPWCA, is Professor, Public Health Sciences and Medicine, University of Toronto, Director of Toronto Regional Wound Clinics, Toronto, Ontario, Canada; Director of the International Interprofessional Wound Care Course at the University of Toronto and President of the World Union of Wound Healing Societies; Patricia Coutts, RN, IIWCC, is President, Canadian Association of Wound Care, and Clinical Care Director, Toronto Regional Wound Clinics, Toronto; Kevin Y. Woo, PhD, RN, ACNP, GNC(C), FAPWCA, is Director of Nursing/Wound Care Specialist, Villa Colombo Homes for the Aged, Inc, Toronto, Ontario, Canada; Wound Care Consultant, West Park Healthcare Centre, Toronto; Assistant Professor, Lawrence S. Bloomberg Faculty of Nursing, University of Toronto; and Associate Director, International Interprofessional Wound Care Course, MScCH Program, University of Toronto.
Submitted March 11, 2010; accepted in revised form November 11, 2010.