Mass Continous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision

Not Applicable

Completed

• Conditions: Surgical Wound; Suture, Complication
• Interventions: Procedure: Mass continous suture with PDS; Procedure: Interrupted suture with thread

• Registration Number: NCT03801421
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

A better suture technology will reduce postoperative incision complications. This study is designed to compare mass continous suture with PDS and interrupted suture with thread on major abdominal incision.

Detailed Description

A better suture technology will reduce postoperative incision complications. The previous retrospective cohort study from the investigator has demonstrated that continuous mass suture with PDS led to shorter incision closure time, early wound healing and comparable incisional complications versus interrupted thread suture. As such, the current RCT study will include 100 subjects with major abdominal incision. They will be divided into two groups randomly: Mass suture gorup, mass continuous suture with PDS, Control group, interrupted suture with thread. The wound healing time, stitches removal time and incidence of incision complications will be compared between the two groups.

Study Timeline

• Study First Submitted: 2019-01-06
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-11
• Study Start: 2019-02-01
• Primary Completion: 2021-03-16
• Study Completion: 2021-03-16
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• the patient with major abdominal incision.
• the incision is longer than 10 cm
• aged between 18 to 65 years old

Exclusion Criteria

• Pregnant woman
• Patient with diabetes
• Patient with a history of cardiovascular disease, including coronary heart disease and stroke.
• Severe lung diseases such as COPD and asthma
• Patients undergoing emergent or infectious surgery
• Patients with surgical site infection
• No autonomy, inability or unwillingness to participate in follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continous suture group	Mass continous suture with PDS	The surgical incision will be treated by mass continous suture with PDS.
Control group	Interrupted suture with thread	The surgical incision will be treated by interrupted suture with thread.

Primary Outcome Measures

Name	Time	Method
healing time, d (day)	Up to 1 month after surgery	Time duration between the date of surgery to the date of stitches off

Secondary Outcome Measures

Name	Time	Method
incidence of incision complications	Up to 1 month after surgery	The incision complications include infection, dehiscence, fat liquefaction, and so on.

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China