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澳大利亚格里菲斯大学Brigid M Gillespie团队比较了肥胖妇女剖宫产术采用闭合切口负压伤口治疗与标准敷料治疗的预后。2021年5月5日，该研究发表在《英国医学杂志》上。

为了探讨闭合切口负压伤口治疗（NPWT）与标准敷料预防肥胖妇女剖宫产术后手术部位感染（SSI）的效果，2015年10月至2019年11月，研究组在澳大利亚的4所三级医院进行了一项多中心、实用、随机、对照、平行组、优势试验，招募孕前体重指数为30或以上的女性，通过选择性或半紧急剖腹产分娩。

2035名同意接受剖腹产手术的女性被随机分为两组，其中闭合切口NPWT组1017名，标准敷料组1018名。主要结局为SSI的累积发生率。次要结局包括SSI深度（浅、深或器官/体腔）、伤口并发症（裂开、血肿、浆膜瘤、出血、瘀伤）、住院时间和敷料相关不良事件的发生率。

在初步意向治疗分析中，75例（7.4%）采用闭合切口NPWT治疗的女性和99例（9.7%）采用标准敷料治疗的女性发生SSI，风险比为0.76。事后敏感性分析，探讨缺失数据的影响，发现闭合切口NPWT降低SSI具有统计学意义。采用闭合切口NPWT治疗的女性中有4.0%发生水疱，显著高于采用标准敷料治疗的女性（2.3%）。

研究结果表明，与标准敷料相比，肥胖妇女剖宫产术应用预防性闭合切口NPWT使SSI风险降低24%，绝对风险降低3%。

附：英文原文

Title: Closed incision negative pressure wound therapy versus standard dressings in obese women undergoing caesarean section: multicentre parallel group randomised controlled trial

Author: Brigid M Gillespie, Joan Webster, David Ellwood, Lukman Thalib, Jennifer A Whitty, Kassam Mahomed, Vicki Clifton, Sailesh Kumar, Adam Wagner, Evelyn Kang, Wendy Chaboyer

Issue&Volume: 2021/05/05

Abstract:

Objective To determine the effectiveness of closed incision negative pressure wound therapy (NPWT) compared with standard dressings in preventing surgical site infection (SSI) in obese women undergoing caesarean section.

Design Multicentre, pragmatic, randomised, controlled, parallel group, superiority trial.

Setting Four Australian tertiary hospitals between October 2015 and November 2019.

Participants Eligible women had a pre-pregnancy body mass index of 30 or greater and gave birth by elective or semi-urgent caesarean section.

Intervention 2035 consenting women were randomised before the caesarean procedure to closed incision NPWT (n=1017) or standard dressing (n=1018). Allocation was concealed until skin closure.

Main outcome measures The primary outcome was cumulative incidence of SSI. Secondary outcomes included depth of SSI (superficial, deep, or organ/body space), rates of wound complications (dehiscence, haematoma, seroma, bleeding, bruising), length of stay in hospital, and rates of dressing related adverse events. Women and clinicians were not masked, but the outcome assessors and statistician were blinded to treatment allocation. The pre-specified primary intention to treat analysis was based on a conservative assumption of no SSI for a minority of women (n=28) with missing outcome data. Post hoc sensitivity analyses included best case analysis and complete case analysis.

Results In the primary intention to treat analysis, SSI occurred in 75 (7.4%) women treated with closed incision NPWT and in 99 (9.7%) women with a standard dressing (risk ratio 0.76, 95% confidence interval 0.57 to 1.01; P=0.06). Post hoc sensitivity analyses to explore the effect of missing data found the same direction of effect (closed incision NPWT reducing SSI), with statistical significance. Blistering occurred in 40/996 (4.0%) women who received closed incision NPWT and in 23/983 (2.3%) who received the standard dressing (risk ratio 1.72, 1.04 to 2.85; P=0.03).

Conclusion Prophylactic closed incision NPWT for obese women after caesarean section resulted in a 24% reduction in the risk of SSI (3% reduction in absolute risk) compared with standard dressings. This difference was close to statistical significance, but it likely underestimates the effectiveness of closed incision NPWT in this population. The results of the conservative primary analysis, multivariable adjusted model, and post hoc sensitivity analysis need to be considered alongside the growing body of evidence of the benefit of closed incision NPWT and given the number of obese women undergoing caesarean section globally. The decision to use closed incision NPWT must also be weighed against the increases in skin blistering and economic considerations and should be based on shared decision making with patients.

DOI: 10.1136/bmj.n893

Source: https://www.bmj.com/content/373/bmj.n893

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