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


METHODS
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.
University of Toronto, Ontario, Canada.
R Gary
RG
Sibbald
Patricia
P
Coutts
Kevin Y
KY
Woo
D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D001458:Bandages; D001645:Biguanides / Q000008:administration & dosage*; D002170:Canada; D002908:Chronic Disease; D015169:Colony Count, Microbial; D005260:Female; D006801:Humans; D007871:Leg Ulcer / Q000382:microbiology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D010865:Pilot Projects; D003668:Pressure Ulcer / Q000150:complications / Q000382:microbiology / Q000628:therapy*; D016896:Treatment Outcome; D014945:Wound Healing
D000900:Anti-Bacterial Agents; D000891:Anti-Infective Agents, Local; D001645:Biguanides; C031233:polihexanide