Effect of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Diseases (BARBHER) (BARBHER)

November 23, 2020 updated by: Kidong Kim, Seoul National University Hospital

Effects of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Disease (BARBHER)

Investigators will compare the incidence of incisional hernia in women who underwent midline laparotomy whose abdominal fascia was closed with barbed suture vs. conventional non-barbed suture.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Anticipating midline laparotomy for gynecologic diseases
  • ECOG performance status 0 - 2

Exclusion Criteria:

  • Previous or current abdominal incisional hernia
  • Pregnant
  • Previous radiation on abdomen area
  • Allergy to PDS or irgacare MP
  • Having disease affecting wound healing such as uncontrolled DM, autoimmune vasculitis, liver cirrhosis, coagulopathy
  • BMI > 35
  • Current or anticipated use of drugs affecting wound healing such as bevacizumab (with 4 week drug free period, bevacizumab user is eligible)
  • Abdominal midline laparotomy within 6 months
  • Surgery for infection control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
Abdominal fascia will be closed with barbed suture.
Device: Barbed PDS suture (STRATAFIX Symmetric PDS Plus)
STRATAFIX Symmetric PDS Plus is a barbed suture.
Active Comparator: Control
Abdominal fascia will be closed with non-barbed suture.
Device: Non-barbed PDS suture (PDS Plus)
Non-barbed suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of incisional hernia
Time Frame: from surgery to 1 year
Incisional hernia till 1 year after surgery
from surgery to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-event curve of incisional hernia
Time Frame: from surgery to 1 year
from surgery to 1 year
Cumulative incidence of surgical site infection
Time Frame: from surgery to 4weeks
from surgery to 4weeks
Incidence of wound dehiscence
Time Frame: post-surgery 4weeks
post-surgery 4weeks
Brief Pain Inventory - Korean (BPI-K) score
Time Frame: Baseline, postoperative day 2, 4
Pain measured with BPI-K Specifically score (0-10 all domain, higher score mean worse outcome) in domain of worst pain, least pain, average pain, current pain, impact of pain in general activity, mood, work, relationship, ambulation, sleep and happiness
Baseline, postoperative day 2, 4
Treatment related adverse event
Time Frame: from surgery to 1 year
from surgery to 1 year
NRS
Time Frame: from surgery to postoperative 4 day
pain captured by NRS in nursing record, 0-10, higher score means more pain
from surgery to postoperative 4 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

November 11, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Actual)

November 25, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGOG 4001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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