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预防性单次使用负压伤口敷料在切口疝修补术后闭合性手术伤口中的应用:一项随机对照试验。

Prophylactic Single-use Negative Pressure Dressing in Closed Surgical Wounds After Incisional Hernia Repair: A Randomized, Controlled Trial.

机构信息

Surgical Unit of Abdominal Wall. Department of Digestive Surgery, "La Fe" Hospital, University of Valencia, Valencia, Spain.

出版信息

Ann Surg. 2021 Jun 1;273(6):1081-1086. doi: 10.1097/SLA.0000000000004310.

Abstract

OBJECTIVE

A randomized controlled trial (RCT) was undertaken to evaluate whether the prophylactic application of a specific single-use negative pressure (sNPWT) dressing on closed surgical incisions after incisional hernia (IH) repair decreases the risk of surgical site occurrences (SSOs) and the length of stay.

BACKGROUND

The sNPWT dressings have been associated to several advantages like cost savings and prevention of SSOs like seroma, hematoma, dehiscence, or wound infection (SSI) in closed surgical incisions. But this beneficious effect has not been previously studied in cases of close wounds after abdominal wall hernia repairs.

METHODS

An RCT was undertaken between May 2017 and January 2020 (ClinicalTrials.gov registration number NCT03576222). Participating patients, with IH type W2 or W3 according to European Hernia Society classification, were randomly assigned to receive intraoperatively either the sNPWT (PICO)(72 patients) or a conventional dressing at the end of the hernia repair (74 patients). The primary endpoint was the development of SSOs during the first 30 days after hernia repair. The secondary endpoint included length of hospital stay. Statistical analysis was performed using IBM SPSS Statistics Version 23.0.

RESULTS

At 30 days postoperatively, there was significatively higher incidence of SSOs in the control group compared to the treatment group (29.8% vs 16.6%, P < 0.042). There was no SSI in the treatment group and 6 cases in the control group (0% vs 8%, P < 0.002). No significant differences regarding seroma, hematoma, wound dehiscence, and length of stay were observed between the groups.

CONCLUSION

The use of prophylactic sNPWT PICO dressing for closed surgical incisions following IH repair reduces significatively the overall incidence of SSOs and the SSI at 30 days postoperatively.

摘要

目的

一项随机对照试验(RCT)评估了在切口疝(IH)修复后的闭合手术切口预防性应用特定的即用型负压(sNPWT)敷料是否降低手术部位并发症(SSO)的风险和住院时间。

背景

sNPWT 敷料具有许多优点,例如节省成本和预防闭合手术切口处的 SSO,如血清肿、血肿、裂开或伤口感染(SSI)。但在腹壁疝修复后的闭合伤口中,尚未对这种有益作用进行过研究。

方法

一项 RCT 于 2017 年 5 月至 2020 年 1 月进行(ClinicalTrials.gov 注册号 NCT03576222)。根据欧洲疝学会分类,患有 IH 类型 W2 或 W3 的患者被随机分配接受术中 sNPWT(PICO)(72 例)或疝修复结束时的常规敷料(74 例)。主要终点是疝修复后 30 天内发生 SSO。次要终点包括住院时间。使用 IBM SPSS Statistics Version 23.0 进行统计分析。

结果

术后 30 天,对照组 SSO 的发生率明显高于治疗组(29.8% vs 16.6%,P < 0.042)。治疗组无 SSI,对照组有 6 例(0% vs 8%,P < 0.002)。两组间在血清肿、血肿、伤口裂开和住院时间方面无显著差异。

结论

在 IH 修复后的闭合手术切口预防性应用 sNPWT PICO 敷料可显著降低术后 30 天内 SSO 的总体发生率和 SSI。

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