跳至主要内容
临床试验/NCT06865807
NCT06865807招募中不适用

Influence of Suture Type on Emergency Midline Laparotomy Closure

Hospital San Juan de Dios Tenerife1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Evisceration

研究概览

简要总结

There is no clear recommendation in international guidelines regarding the type of suture to be used for closing emergency midline laparotomies. It is recommended to follow the same principles as in elective surgery, thus performing the closure with a continuous suture of slowly absorbable monofilament 2-0 with small-bites technique. Currently, there are several slowly absorbable sutures available on the market, and our center uses two: PDS® and Monomax®. These two sutures are currently used interchangeably at our institution based on the preferences of each surgeon.

Objective: study whether there are differences between these two sutures in the closure of emergency midline laparotomy.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •>18 years old, patients undergoing emergency midline laparotomy by the General Surgery Department.

排除标准

  • •<18 years old, previous midline laparotomy

研究组 & 干预措施

PDS

Active Comparator

Closure emergency laparotomy using PDS 2/0 small bites

干预措施: PDS 2/0 vs Monomax 2/0 (Procedure)

Monomax

Experimental

Closure emergency laparotomy using Monomax 2/0 small bites

干预措施: PDS 2/0 vs Monomax 2/0 (Procedure)

结局指标

主要结局

Evisceration

时间窗: 1 month

Rate of evisceration

次要结局

  • Wound complication(1 month)
  • Incisional hernia(1 year)

研究者

发起方
Hospital San Juan de Dios Tenerife
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julen Ramon Rodríguez

Principal Investigator

University Hospital of the Nuestra Señora de Candelaria

研究点 (1)

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