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A comparison of collagenase to hydrogel dressings in maintenance debridement and wound closure.

医学 胶原酶 伤口愈合 清创术(牙科) 外科 随机化 精确检验 统计显著性 随机对照试验 内科学 化学 生物化学
作者
Catherine T. Milne,Armann Ciccarelli,Mandie Lassy
出处
期刊:PubMed 卷期号:24 (11): 317-22 被引量:23
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 The role of maintenance debridement in wound healing has been well described, yet little is known regarding comparative methods and associated outcomes with this process when using collagenase or hydrogel.Evaluation of maintenance debridement and wound closure with collagenase compared to hydrogel in institutionalized adults with pressure ulcers from time of necrotic tissue removal up to 84 days from enrollment.This second phase of a rollover evaluation enrolled only subjects who successfully completed phase 1 (previously reported) from time of necrotic tissue debridement. Subjects received daily dressing changes with either hydrogel or collagenase followed by a standard semiocclusive dressing to evaluate wound-healing parameters and wound closure from initial enrollment to day 84. Investigators blinded to randomization evaluated weekly wound photographs using a digital planimetry software package for wound-healing parameters. Additionally, Pressure Ulcer Scale for Healing (PUSH) © Tool and wound bed scores (WBS) were monitored.Eleven of 13 subjects from the collagenase group entered into phase 2, with 4 of the 14 subjects from the hydrogel group. One subject from each group was eliminated within the first week of phase 2. All subjects (n = 3) in the hydrogel group reached complete epithelialization with a mean of 32.6 days. Nine of 10 subjects in the collagenase group reached completed epithelialization with a mean of 45 days. An independent samples t test showed no statistical significance between the 2 groups (P = 0.121) in days to healing. A Fisher's exact test performed on the primary endpoint of complete epithelialization also demonstrated no significant difference in outcomes between the groups (P = 0.99). Mean WBS at the onsetof phase 2 was 13.7 (range 12-16), and the PUSH Tool mean score was 1.0 (range 0-3). In aggregating phase 1 and phase 2 data, a difference in the closure rates at the end of the study, 69% (collagenase) vs 21% (hydrogel), was statically significant (P = 0.0213) using a Fisher's exact test.Facilitating maintenance debridement by either collagenase or hydrogel can be used to complete wound closure when used in conjunction with a validated predictive wound-healing tool that closely monitors therapy. This study showed statistical significance in favor of collagenase when evaluating closure rates from the onset of the pressure ulcer. .

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