Suture Closure versus Non-Closure of Subcutaneous Fat and Cosmetic Outcome after Cesarean Section: A Randomized Controlled Trial

Introduction
To investigate the effect of subcutaneous fat suture closure versus non-closure at cesarean section (CS) on long-term cosmetic outcome.
Material and Methods
Women undergoing planned or unplanned CS were randomized to either subcutaneous fat suture closure or non-closure using a 1∶1 allocation algorithm. Participants and outcome assessors were blinded to group allocation. Scar evaluation was performed after two and six months. Primary outcome measures were Patient and Observer Scar Assessment Scale (POSAS) summary scores six months after surgery. Secondary outcome measures were Vancouver Scar Scale (VSS) summary scores, retraction of the scar below the level of the surrounding skin, duration of surgery, and development of hematoma, seroma, surgical site infection (SSI) or wound disruption. Data were analyzed according to the intention to treat principle.
Results
A total of 116 women were randomized and 91 participants, 47 in the closure and 44 in the non-closure group, completed the trial and were analyzed. There were no differences in patient morphometrics or surgery indications between groups. At two and six months no significant differences were found with respect to POSAS or VSS scores between groups. After two months significantly more women in the non-closure group described their scar as being retracted below the level of the skin (36% vs. 15%, p = 0.02) whereas no difference was observed at six months. There were significantly more hematomas in the non-closure (25%) compared to the closure group (4%) (p = 0.005). There was no difference in duration of surgery, SSI, seroma formation or wound disruption between groups.
Conclusions
Suture closure of the subcutaneous fat at CS does not affect long-term cosmetic outcome. (Level I evidence).
Trial Registration
ClinicalTrials.gov NCT01542346.

引言
本研究旨在探讨剖宫产（Cesarean Section, CS）术中皮下脂肪层缝合与不缝合对远期美容效果的影响。

材料与方法
将计划或急诊剖宫产的产妇按照1:1随机分配方案分为皮下脂肪层缝合组与不缝合组。研究参与者与结局评估者均设盲，不知晓分组情况。分别于术后2个月与6个月对手术瘢痕进行评估。主要结局指标为术后6个月的患者与观察者瘢痕评估量表（Patient and Observer Scar Assessment Scale, POSAS）总评分。次要结局指标包括温哥华瘢痕量表（Vancouver Scar Scale, VSS）总评分、瘢痕低于周围皮肤水平的回缩程度、手术时长，以及血肿、血清肿、手术部位感染（surgical site infection, SSI）或伤口裂开的发生情况。数据采用意向性治疗原则进行分析。

结果
共计116名产妇接受随机分组，其中91名完成试验并纳入分析：缝合组47例，不缝合组44例。两组产妇的人体测量学指标与手术指征均无显著差异。术后2个月与6个月时，两组的POSAS与VSS评分均无显著差异。术后2个月时，不缝合组有更多产妇报告其瘢痕低于周围皮肤水平（36% vs. 15%，p=0.02），而术后6个月时两组未观察到此类差异。不缝合组的血肿发生率（25%）显著高于缝合组（4%，p=0.005）。两组的手术时长、SSI发生率、血清肿形成率与伤口裂开率均无显著差异。

结论
剖宫产术中皮下脂肪层缝合与否不影响远期美容效果（证据级别：I级）。

试验注册
ClinicalTrials.gov NCT01542346