一项关于 I 型胶原蛋白基质加聚六亚甲基双胍抗菌剂治疗静脉溃疡的前瞻性非干预性研究：二次分析。

A Prospective Noninterventional Study of Type I Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial for the Treatment of Venous Leg Ulcers: A Secondary Analysis.

机构信息

Department of Surgery, Division of Vascular and Endovascular Surgery, Stony Brook School of Medicine, Stony Brook, New York.

Medical Director Outpatient Wound and Hyperbaric Medicine Center, Department of Plastic Surgery, Hoag Hospital, Newport Beach and Irvine, California.

出版信息

Wound Manag Prev. 2022 Jun;68(6):11-17.

PMID:35895031

Abstract

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.

摘要

背景

RESPOND 登记研究是第一项评估天然 1 型胶原蛋白基质加聚六亚甲基双胍抗菌（PCMP）屏障在非愈合性伤口中的真实世界疗效的前瞻性非干预性研究。

目的

本二次分析的目的是描述 PCMP 在 RESPOND 登记研究中静脉性溃疡（VLU）患者亚组中的作用。

方法

RESPOND 是一项 28 个地点的前瞻性非干预性研究，最长 32 周。RESPOND 中的所有患者（N=307）均接受 PCMP 治疗。入选标准包括年龄 18 岁及以上，有皮肤伤口，但不包括三度烧伤。Kaplan-Meier 方法分析了伤口闭合的频率和中位数时间。

结果

对于接受 PCMP 治疗的 VLU 队列（n=67），平均基线伤口面积为 20.07cm2，平均伤口持续时间为 89 天。分别在第 8、12、16、24 和 32 周时，伤口闭合频率为 33%、42%、45%、53%和 73%。中位闭合时间为 22 周。基线面积和深度分别有 78%和 70%达到>60%减少的发生率，87%的体积减少>75%。