Reduction of bacterial burden and pain in chronic wounds using a new polyhexamethylene biguanide antimicrobial foam dressing: clinical trial results

  • R G Sibbald
  • P Coutts
  • K Y Woo
Keywords: polyhexamethylene biguanide foam dressing, antimicrobial foam dressing, reduction of bacterial burden and pain in chronic wounds

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

Author Biographies

R G Sibbald
BSc, MD, MEd, FRCPC (Med Derm), MACP, FAAD, MAPWCA
P Coutts
RN, IIWCC
K Y Woo
PhD, RN, ACNP, GNC(C), FAPWCA
Section
Original Research