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局部应用庆大霉素-胶原海绵对皮瓣切除并一期缝合后切口愈合或复发率无改善:一项前瞻性随机对照试验。

Local administration of antibiotics by gentamicin-collagen sponge does not improve wound healing or reduce recurrence rate after pilonidal excision with primary suture: a prospective randomized controlled trial.

机构信息

Department of Surgery, Länssjukhuset Ryhov, 551 85, Jönköping, Sweden.

出版信息

World J Surg. 2010 Dec;34(12):3042-8. doi: 10.1007/s00268-010-0763-2.

DOI:10.1007/s00268-010-0763-2
PMID:20734046
Abstract

BACKGROUND

Excision and primary suture for pilonidal disease is associated with a high rate of wound infection and recurrences. This randomized, controlled study was designed to analyze the effect of local application of a gentamicin-containing collagen sponge (Collatamp(®)) in reducing the wound infection rate and recurrences after excision of pilonidal sinus and wound closure with primary midline suture.

METHODS

From March 2003 to November 2005, 161 patients with symptomatic pilonidal disease were operated on at 11 hospitals with traditional wide excision of the sinus and all of its tracts. The patients were randomized to filling of the cavity with a gentamicin-containing collagen sponge (Collatamp(®)) before wound closure or to closure with no additional treatment. Information about the treatment allocation was hidden until the end of the study. Information about wound healing was noted at follow-up at the outpatient department after 2-4 days, 2 weeks, 3 months, and 1 year.

RESULTS

No statistically significant differences were observed between the groups during follow-up. Patients who received prophylaxis with Collatamp(®) had slightly fewer wounds with exudate at 2-4 days and 2 weeks of follow-up (2% vs. 10%, p = 0.051 and 57% vs. 65%, p = 0.325, respectively), a slightly larger proportion of healed wounds at 3 months follow-up (77% vs. 66%, p = 0.138) but not at 1 year (85% vs. 90%, p = 0.42, respectively), and slightly more reoperations (10% vs. 4%, p = 0.213).

CONCLUSIONS

This randomized, controlled study showed no significant differences in the rates of wound infection, wound healing, and recurrences when a gentamicin-collagen sponge was added to the surgical treatment of pilonidal disease with excision and primary midline suture. This does not support the use of gentamicin-collagen sponge for the surgical treatment of pilonidal disease.

摘要

背景

对于藏毛窦疾病,切除和一期缝合相关的伤口感染和复发率很高。本随机对照研究旨在分析局部应用庆大霉素胶原海绵(Collatamp®)对降低切除藏毛窦后伤口感染率和复发率的影响,并用一期中线缝合闭合伤口。

方法

2003 年 3 月至 2005 年 11 月,161 例有症状的藏毛窦疾病患者在 11 家医院接受传统的窦道及其所有分支的广泛切除手术。患者被随机分为在伤口闭合前用含庆大霉素的胶原海绵(Collatamp®)填充空腔或不做任何附加治疗。治疗分配信息在研究结束时才被揭示。在门诊随访 2-4 天、2 周、3 个月和 1 年时记录伤口愈合情况。

结果

在随访期间,两组之间没有观察到统计学上的显著差异。接受 Collatamp®预防治疗的患者在 2-4 天和 2 周的随访时伤口渗出液略少(2%对 10%,p=0.051 和 57%对 65%,p=0.325),3 个月随访时愈合的伤口比例略大(77%对 66%,p=0.138),但在 1 年时没有差异(85%对 90%,p=0.42),并且略多的再次手术(10%对 4%,p=0.213)。

结论

本随机对照研究表明,在切除和一期中线缝合治疗藏毛窦疾病时,添加庆大霉素胶原海绵与伤口感染、伤口愈合和复发率无显著差异。因此,不支持使用庆大霉素胶原海绵治疗藏毛窦疾病。

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