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

NCT ID: NCT03801421

Last Updated: 2021-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2021-03-16

Brief Summary

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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

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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.

Conditions

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Surgical Wound Suture, Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continous suture group

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

Group Type EXPERIMENTAL

Mass continous suture with PDS

Intervention Type PROCEDURE

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

Control group

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

Group Type ACTIVE_COMPARATOR

Interrupted suture with thread

Intervention Type PROCEDURE

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

Interventions

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Mass continous suture with PDS

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

Intervention Type PROCEDURE

Interrupted suture with thread

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Zhang Xu-Feng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xu-Feng Zhang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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XJTU1AFCRC2017SJ-007-2

Identifier Type: -

Identifier Source: org_study_id

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