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

Surgical Wound Clinical Trial

Official title:

Mass Continuous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801421
• Other study ID #: XJTU1AFCRC2017SJ-007-2
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: March 16, 2021

Study information

• Verified date: May 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound
• Suture, Complication

Intervention

Procedure:
• Mass continous suture with PDS
The surgical incision will be treated by mass continous suture with PDS.
• Interrupted suture with thread
The surgical incision will be treated by interrupted suture with thread.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healing time, d (day)	Time duration between the date of surgery to the date of stitches off	Up to 1 month after surgery
Secondary	incidence of incision complications	The incision complications include infection, dehiscence, fat liquefaction, and so on.	Up to 1 month after surgery