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临床试验/NCT07683546
NCT07683546尚未招募不适用

A Randomized Trial of Duramesh Versus PDS Loop Suture for Midline Incision Fascial Abdominal Closure Evaluation in Patients With Gynecological Malignancies

Aristotle University Of Thessaloniki0 个研究点目标入组 300 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
主要终点
Incidence of incisional hernia

研究概览

简要总结

FACE (Fascial Abdominal Closure Evaluation) Trial is a prospective, single center, open-label, randomized trial of Duramesh versus PDS loop suture for midline incision fascial abdominal closure evaluation in patients with gynecological malignancies

详细描述

Incisional hernias after midline incisions are estimated are estimated around 10-20%, which many times results in further surgical procedures. Many techniques with different sutures have been proposed of the years for fascial closure. PDS suture offers longer dissolution time, lower short-term tensile strength and lower knot security, however the highest quality data available for gynecological malignancies are from 30 years ago. On the other hand, the use of mesh suture (Duramesh) has been proposed as an alternative, in order to reduce postoperative hernias and abdominal wall complication rates. A recent systematic review on Duramesh shows promising results with a median incisional hernia occurrence of 3.4%, but the authors highlight the need for high-quality randomized controlled trials with long-term follow-up to evaluate the clinical benefits of Duramesh.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Midline laparotomies for gynecological malignancies
  • Age 18 - 85 years old
  • ECOG Performance status: 0 - 2

排除标准

  • Pregnancy
  • Albumin < 3.5 g/dL
  • Previous history of any type of hernia
  • Previous midline incision (via laparotomy)

结局指标

主要结局

Incidence of incisional hernia

时间窗: Up to 12 months after randomization

Clinical or radiological detected

次要结局

  • Incidence of wound dehiscence(Up to 1 month after randomization)
  • Incidence of wound infection(Up to 1 months after randomization)
  • Visual Analogue Scale (VAS) for wound pain(Fifth postoperative day after randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitrios Zouzoulas

Gynecological Oncologist, MSc, PhD, FEBS-BS, FESGO-EBCOG

Aristotle University Of Thessaloniki

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