Hondé C, Derks C, Tudor D
Synthélabo Recherche, Recherche Clinique, Bagneux, France.
J Am Geriatr Soc. 1994 Nov;42(11):1180-3. doi: 10.1111/j.1532-5415.1994.tb06985.x.
To compare the clinical effectiveness and wound management properties of a copolymer membrane, Inerpan (Synthélabo), and a hydrocolloid dressing, Comfeel (Coloplast), in the treatment of decubitus ulcers in the elderly.
Open, randomized, multicentric French study, with two parallel groups of patients.
168 in-patients aged more 65 years (mean age: 82 years) suffering from grade II to grade IV (in the Shea classification) pressure sores. TRIAL PERIOD: Either 8 weeks or until the ulcer healed, whichever occurred first.
In addition to a complete physical examination, patients were evaluated at baseline for nutritional status and risk factors. The wounds were described, their depth scored, and the areas traced at Weeks 0, 1, 2, 4, 6, and 8. The number of dressings used was recorded.
Thirty-one Inerpan-treated patients and 23 Comfeel-treated patients achieved healing (P = 0.089), with respective median healing times of 32 and 38 days. Healing times were compared using survival curves (in the whole population) adjusted for ulcer depth effect and showed a significant difference in favor of Inerpan (P = 0.044 and 0.014). Progress of healing (percentage of ulcer healed) was calculated in the two groups. Clinically assessed the treatment performance scored at the completion of the study showed better results with Inerpan (P < 0.05). Both groups were similar in terms of granulation/exudation scores, surrounding skin, and ease of care.
It is concluded that Inerpan is easy to use, safeguards the healing process, and is of particular value in the management of pressure sores.
比较一种共聚物膜（Inerpan，赛诺菲公司生产）和一种水胶体敷料（Comfeel，康乐保公司生产）在治疗老年人褥疮方面的临床疗效及伤口处理特性。
开放性、随机、多中心法国研究，有两组平行患者。
168名65岁以上住院患者（平均年龄：82岁），患有II至IV级（根据谢伊分类法）压疮。
8周或直至溃疡愈合，以先发生者为准。
除全面体格检查外，患者在基线时还接受营养状况和危险因素评估。在第0、1、2、4、6和8周时对伤口进行描述、记录深度并描绘面积。记录使用的敷料数量。
31名接受Inerpan治疗的患者和23名接受Comfeel治疗的患者实现愈合（P = 0.089），各自的中位愈合时间为32天和38天。使用根据溃疡深度影响进行调整的生存曲线（在全体患者中）比较愈合时间，结果显示Inerpan具有显著优势（P = 0.044和0.014）。计算两组的愈合进展（溃疡愈合百分比）。在研究结束时临床评估的治疗表现评分显示Inerpan效果更好（P < 0.05）。两组在肉芽组织/渗出物评分、周围皮肤情况和护理难易程度方面相似。
得出结论，Inerpan易于使用，能保障愈合过程，在压疮处理中具有特殊价值。
