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Clinical Trials/NCT04643197
NCT04643197UnknownNot Applicable

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

Seoul National University Hospital0 sites174 target enrollmentStarted: December 1, 2020Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
174
Primary Endpoint
Cumulative incidence of incisional hernia
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Years to 85 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Previous or current abdominal incisional hernia
  • •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

Arms & Interventions

Experimental arm

Experimental

Abdominal fascia will be closed with barbed suture.

Intervention: Barbed PDS suture (STRATAFIX Symmetric PDS Plus) (Device)

Control

Active Comparator

Abdominal fascia will be closed with non-barbed suture.

Intervention: Non-barbed PDS suture (PDS Plus) (Device)

Outcomes

Primary Outcomes

Cumulative incidence of incisional hernia

Time Frame: from surgery to 1 year

Incisional hernia till 1 year after surgery

Secondary Outcomes

  • Time-event curve of incisional hernia(from surgery to 1 year)
  • Cumulative incidence of surgical site infection(from surgery to 4weeks)
  • Incidence of wound dehiscence(post-surgery 4weeks)
  • Brief Pain Inventory - Korean (BPI-K) score(Baseline, postoperative day 2, 4)
  • Treatment related adverse event(from surgery to 1 year)
  • NRS(from surgery to postoperative 4 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kidong Kim

Professor

Seoul National University Bundang Hospital

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