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

Primary Purpose

Surgical Wound, Suture, Complication

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mass continous suture with PDS
Interrupted suture with thread
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound focused on measuring Surgical Wound, Suture, Complication

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Xi'an Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continous suture group

Control group

Arm Description

The surgical incision will be treated by mass continous suture with PDS.

The surgical incision will be treated by interrupted suture with thread.

Outcomes

Primary Outcome Measures

healing time, d (day)
Time duration between the date of surgery to the date of stitches off

Secondary Outcome Measures

incidence of incision complications
The incision complications include infection, dehiscence, fat liquefaction, and so on.

Full Information

First Posted
January 6, 2019
Last Updated
May 18, 2021
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT03801421
Brief Title
Mass Continous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision
Official Title
Mass Continuous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
March 16, 2021 (Actual)
Study Completion Date
March 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound, Suture, Complication
Keywords
Surgical Wound, Suture, Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continous suture group
Arm Type
Experimental
Arm Description
The surgical incision will be treated by mass continous suture with PDS.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The surgical incision will be treated by interrupted suture with thread.
Intervention Type
Procedure
Intervention Name(s)
Mass continous suture with PDS
Intervention Description
The surgical incision will be treated by mass continous suture with PDS.
Intervention Type
Procedure
Intervention Name(s)
Interrupted suture with thread
Intervention Description
The surgical incision will be treated by interrupted suture with thread.
Primary Outcome Measure Information:
Title
healing time, d (day)
Description
Time duration between the date of surgery to the date of stitches off
Time Frame
Up to 1 month after surgery
Secondary Outcome Measure Information:
Title
incidence of incision complications
Description
The incision complications include infection, dehiscence, fat liquefaction, and so on.
Time Frame
Up to 1 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu-Feng Zhang, MD, PhD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China

12. IPD Sharing Statement

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

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