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

Seoul National University

Status: Unknown

Conditions: Gynecologic Disease

Treatments: Device: Non-barbed PDS suture (PDS Plus); Device: Barbed PDS suture (STRATAFIX Symmetric PDS Plus)

Study type: Interventional

Funder types: Other

Identifiers

NCT04643197

KGOG 4001

Details and patient eligibility

About

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.

Enrollment: 174 estimated patients

Sex: Female

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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174 participants in 2 patient groups

Experimental arm

Experimental group

Description:

Abdominal fascia will be closed with barbed suture.

Treatment:

Device: Barbed PDS suture (STRATAFIX Symmetric PDS Plus)

Control

Active Comparator group

Description:

Abdominal fascia will be closed with non-barbed suture.

Treatment:

Device: Non-barbed PDS suture (PDS Plus)