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.
RCT Entities:
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.
Authors: Jo C Dumville; Benjamin A Lipsky; Christopher Hoey; Mario Cruciani; Marta Fiscon; Jun Xia Journal: Cochrane Database Syst Rev Date: 2017-06-14
Authors: Joseph M Yabes; Brian K White; Clinton K Murray; Carlos J Sanchez; Katrin Mende; Miriam L Beckius; Wendy C Zera; Joseph C Wenke; Kevin S Akers Journal: Med Mycol Date: 2017-04-01 Impact factor: 4.076