Milne Catherine T, Ciccarelli Armann, Lassy Mandie
Connecticut Clinical Nursing Associates, LLC, Plymouth, CT; email:
Federal Hill Plastic Surgery, Bristol, CT.
Wounds. 2012 Nov;24(11):317-22.
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. .
清创术在伤口愈合中的作用已有充分描述，但对于使用胶原酶或水凝胶进行该过程的比较方法及相关结果却知之甚少。
对比在机构养老的成年压疮患者中，从坏死组织清除至入组后84天，使用胶原酶与水凝胶进行维持性清创和伤口闭合的情况。
本翻转评估的第二阶段仅纳入从坏死组织清创时起成功完成第一阶段（先前已报道）的受试者。受试者每日使用水凝胶或胶原酶换药，随后使用标准半封闭敷料，以评估从初始入组至第84天的伤口愈合参数和伤口闭合情况。对随机分组不知情的研究者使用数字平面测量软件包评估每周的伤口照片，以获取伤口愈合参数。此外，还监测了愈合压疮量表（PUSH）工具和伤口床评分（WBS）。
胶原酶组的13名受试者中有11名进入第二阶段，水凝胶组的14名受试者中有4名进入。每组各有1名受试者在第二阶段的第一周内被排除。水凝胶组的所有受试者（n = 3）平均在32.6天实现完全上皮化。胶原酶组的10名受试者中有9名平均在45天实现完全上皮化。独立样本t检验显示两组在愈合天数上无统计学显著差异（P = 0.121）。对完全上皮化这一主要终点进行的Fisher精确检验也表明两组在结果上无显著差异（P = 0.99）。第二阶段开始时的平均WBS为13.7（范围12 - 16），PUSH工具的平均评分为1.0（范围0 - 3）。汇总第一阶段和第二阶段的数据后，使用Fisher精确检验发现，研究结束时的闭合率存在差异，胶原酶组为69%，水凝胶组为21%，具有统计学显著性（P = 0.0213）。
当与密切监测治疗的有效预测性伤口愈合工具联合使用时，胶原酶或水凝胶促进的维持性清创可用于实现伤口闭合。本研究在评估压疮开始时的闭合率时显示胶原酶具有统计学显著性优势。
