Effect of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Diseases (BARBHER)
NCT ID: NCT04643197
Last Updated: 2020-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
174 participants
INTERVENTIONAL
2020-12-01
2023-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Experimental arm
Abdominal fascia will be closed with barbed suture.
Barbed PDS suture (STRATAFIX Symmetric PDS Plus)
STRATAFIX Symmetric PDS Plus is a barbed suture.
Control
Abdominal fascia will be closed with non-barbed suture.
Non-barbed PDS suture (PDS Plus)
Non-barbed suture
Interventions
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Barbed PDS suture (STRATAFIX Symmetric PDS Plus)
STRATAFIX Symmetric PDS Plus is a barbed suture.
Non-barbed PDS suture (PDS Plus)
Non-barbed suture
Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0 - 2
Exclusion Criteria
* 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
19 Years
85 Years
FEMALE
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Kidong Kim
Professor
Central Contacts
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References
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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.
Other Identifiers
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KGOG 4001
Identifier Type: -
Identifier Source: org_study_id