Abstract：
BACKGROUND: Reversal of ileostomy is associated with morbidity including wound infection and prolonged wound healing. Negative pressure wound therapy (NPWT) has been shown to reduce time to wound healing by secondary intention. The aim of this study was to determine whether NPWT improved wound healing rates, compared with simple wound dressings, in patients undergoing reversal of ileostomy where the skin wound is closed with a purse-string suture.
METHODS: This was a dual-centre, open-label, randomized controlled trial with two parallel intervention arms. Patients undergoing elective loop ileostomy reversal were randomized 1:1 to receive NPWT or simple wound dressings. The primary endpoint of the study was assessment of complete wound healing at day 42 post reversal of ileostomy and the secondary endpoints were patient-reported wound cosmesis using a visual analogue scale and rates of surgical site infection (SSI).
RESULTS: The study was conducted from June 2018 to December 2021. The trial was approved by the local ethics committee. We enrolled 40 patients, 20 in each arm. One patient in each arm was lost to follow up. Nine patients (9/19, 47.36%) in the simple dressing group had wound healing vs. 13 patients (13/19, 68.42%) in the NPWT group (P = 0.188). There was no significant difference in patient- reported wound cosmesis or SSI.
CONCLUSIONS: There was no difference in wound healing rates when comparing NPWT to simple wound dressings at early and late time points post reversal of ileostomy, where the skin wound was closed with a purse-string suture.
METHODS: This was a dual-centre, open-label, randomized controlled trial with two parallel intervention arms. Patients undergoing elective loop ileostomy reversal were randomized 1:1 to receive NPWT or simple wound dressings. The primary endpoint of the study was assessment of complete wound healing at day 42 post reversal of ileostomy and the secondary endpoints were patient-reported wound cosmesis using a visual analogue scale and rates of surgical site infection (SSI).
RESULTS: The study was conducted from June 2018 to December 2021. The trial was approved by the local ethics committee. We enrolled 40 patients, 20 in each arm. One patient in each arm was lost to follow up. Nine patients (9/19, 47.36%) in the simple dressing group had wound healing vs. 13 patients (13/19, 68.42%) in the NPWT group (P = 0.188). There was no significant difference in patient- reported wound cosmesis or SSI.
CONCLUSIONS: There was no difference in wound healing rates when comparing NPWT to simple wound dressings at early and late time points post reversal of ileostomy, where the skin wound was closed with a purse-string suture.
摘要：
背景：回肠造口术的逆转与包括伤口感染和伤口愈合时间延长的发病率相关。负压伤口治疗（NPWT）已被证明可以通过次要意图减少伤口愈合的时间。这项研究的目的是确定NPWT是否改善伤口愈合率，与简单的伤口敷料相比，在接受回肠造口术逆转的患者中，用荷包缝线闭合皮肤伤口。
方法：这是一个双中心，开放标签，两组平行干预组的随机对照试验。接受选择性回肠造口术逆转的患者被随机分为1：1，接受NPWT或简单的伤口敷料。研究的主要终点是评估回肠造口术逆转后第42天的完全伤口愈合，次要终点是使用视觉模拟量表和手术部位感染率（SSI）的患者报告的伤口外观。
结果：该研究于2018年6月至2021年12月进行。该试验得到当地伦理委员会的批准。我们招募了40名患者，每个手臂20每只手臂中有一名患者失去随访。简单敷料组9例（9/19，47.36%）伤口愈合与NPWT组13例(13/19,68.42%)(P=0.188)。患者报告的伤口外观或SSI没有显着差异。
结论：当在回肠造口术逆转后的早期和晚期时间点比较NPWT和简单伤口敷料时，伤口愈合率没有差异，用荷包缝线缝合皮肤伤口。
方法：这是一个双中心，开放标签，两组平行干预组的随机对照试验。接受选择性回肠造口术逆转的患者被随机分为1：1，接受NPWT或简单的伤口敷料。研究的主要终点是评估回肠造口术逆转后第42天的完全伤口愈合，次要终点是使用视觉模拟量表和手术部位感染率（SSI）的患者报告的伤口外观。
结果：该研究于2018年6月至2021年12月进行。该试验得到当地伦理委员会的批准。我们招募了40名患者，每个手臂20每只手臂中有一名患者失去随访。简单敷料组9例（9/19，47.36%）伤口愈合与NPWT组13例(13/19,68.42%)(P=0.188)。患者报告的伤口外观或SSI没有显着差异。
结论：当在回肠造口术逆转后的早期和晚期时间点比较NPWT和简单伤口敷料时，伤口愈合率没有差异，用荷包缝线缝合皮肤伤口。
