NCT04643197

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Status
unknown

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

November 11, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

2.5 years

First QC Date

November 11, 2020

Last Update Submit

November 23, 2020

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of incisional hernia

    Incisional hernia till 1 year after surgery

    from surgery to 1 year

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Experimental arm

EXPERIMENTAL

Abdominal fascia will be closed with barbed suture.

Device: Barbed PDS suture (STRATAFIX Symmetric PDS Plus)

Control

ACTIVE COMPARATOR

Abdominal fascia will be closed with non-barbed suture.

Device: Non-barbed PDS suture (PDS Plus)

Interventions

Barbed PDS suture (STRATAFIX Symmetric PDS Plus)DEVICE

STRATAFIX Symmetric PDS Plus is a barbed suture.

Experimental arm
Non-barbed PDS suture (PDS Plus)DEVICE

Non-barbed suture

Control

Eligibility Criteria

Age19 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Lee YJ, Kim NK, Kim K, Choi CH, Lee KH, Lee JM, Lee KB, Suh DH, Kim S, Kim MK, Seong SJ, Lim MC. Effect of fascial closure using barbed sutures on incisional hernias in midline laparotomy for gynecological diseases: A multicenter randomized controlled trial (KGOG 4001). PLoS One. 2025 Nov 19;20(11):e0337036. doi: 10.1371/journal.pone.0337036. eCollection 2025.

    PMID: 41259380DERIVED

  • Choi CH, Kim NK, Kim K, Lee YJ, Lee KH, Lee JM, Lee KB, Suh DH, Kim S, Kim MK, Seong SJ, Lim MC. Effects of subcutaneous drain on wound dehiscence and infection in gynecological midline laparotomy: Secondary analysis of a Korean Gynecologic Oncology Group study (KGOG 4001). Eur J Surg Oncol. 2024 Sep;50(9):108484. doi: 10.1016/j.ejso.2024.108484. Epub 2024 Jun 12.

    PMID: 38901293DERIVED

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Kidong Kim

CONTACT

82 31 787 7262kidong.kim.md@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 2\*2 factorial design Primary randomization: Barbed suture vs. Non-barbed suture in fascia closure Secondary randomization: subcutaneous drain insertion vs. non-insertion The effect of secondary randomization is one of secondary objectives.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 11, 2020

First Posted

November 25, 2020

Study Start

December 1, 2020

Primary Completion

May 30, 2023

Study Completion

May 31, 2023

Last Updated

November 25, 2020

Record last verified: 2020-11