NCT03801421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

2.1 years

First QC Date

January 6, 2019

Last Update Submit

May 18, 2021

Conditions

Surgical WoundSuture, Complication

Keywords

Surgical WoundSuture, Complication

Outcome Measures

Primary Outcomes (1)

  • healing time, d (day)

    Time duration between the date of surgery to the date of stitches off

    Up to 1 month after surgery

Secondary Outcomes (1)

  • incidence of incision complications

    Up to 1 month after surgery

Study Arms (2)

Continous suture group

EXPERIMENTAL

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

Procedure: Mass continous suture with PDS

Control group

ACTIVE COMPARATOR

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

Procedure: Interrupted suture with thread

Interventions

Mass continous suture with PDSPROCEDURE

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

Continous suture group
Interrupted suture with threadPROCEDURE

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

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Xu-Feng Zhang, MD, PhD

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2019

First Posted

January 11, 2019

Study Start

February 1, 2019

Primary Completion

March 16, 2021

Study Completion

March 16, 2021

Last Updated

May 19, 2021

Record last verified: 2021-05

Locations

CN(1)