Wound management & prevention · 2022
A Prospective Noninterventional Study of Type I Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial for the Treatment of Venous Leg Ulcers: A Secondary Analysis.
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Koullias George J, Bain Michael A, Thibodeaux Kerry, Sabolinski Michael
Аннотация
BACKGROUND: The RESPOND registry study was the first prospective noninterventional study evaluating the real-world effectiveness of a native type 1 collagen matrix plus polyhexamethylene biguanide antimicrobial (PCMP) barrier in nonhealing wounds.
PURPOSE: The objective of this secondary analysis was to describe the effects of PCMP in the subgroup of patients with venous leg ulcers (VLUs) in the RESPOND registry.
METHODS: RESPOND was a 28-site, prospective, noninterventional study for up to 32 weeks. All patients (N = 307) in RESPOND received PCMP. Eligibility criteria included patients being 18 years of age and older and having cutaneous wounds, not including third-degree burns. Kaplan-Meier methods analyzed the frequency and median time to wound closure.
RESULTS: For the cohort of PCMP-treated VLUs (n = 67), the mean baseline wound area was 20.07 cm2 and mean wound duration was 89 days. Wound closure frequencies were 33%, 42%, 45%, 53%, and 73% at weeks 8, 12, 16, 24, and 32, respectively. The median time to closure was 22 weeks. Incidences of achieving >60% reduction in baseline area and depth were 78% and 70%, respectively, with 87% showing a reduction of >75% in volume.
CONCLUSION: PCMP appears to be a valuable adjunct for treating venous leg ulcers.
PURPOSE: The objective of this secondary analysis was to describe the effects of PCMP in the subgroup of patients with venous leg ulcers (VLUs) in the RESPOND registry.
METHODS: RESPOND was a 28-site, prospective, noninterventional study for up to 32 weeks. All patients (N = 307) in RESPOND received PCMP. Eligibility criteria included patients being 18 years of age and older and having cutaneous wounds, not including third-degree burns. Kaplan-Meier methods analyzed the frequency and median time to wound closure.
RESULTS: For the cohort of PCMP-treated VLUs (n = 67), the mean baseline wound area was 20.07 cm2 and mean wound duration was 89 days. Wound closure frequencies were 33%, 42%, 45%, 53%, and 73% at weeks 8, 12, 16, 24, and 32, respectively. The median time to closure was 22 weeks. Incidences of achieving >60% reduction in baseline area and depth were 78% and 70%, respectively, with 87% showing a reduction of >75% in volume.
CONCLUSION: PCMP appears to be a valuable adjunct for treating venous leg ulcers.