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

Gynecologic Disease Clinical Trial

— BARBHER  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04643197
• Other study ID #: KGOG 4001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: November 2020
• Source: Seoul National University Hospital
• Contact: Kidong Kim
• Phone: 82 31 787 7262
• Email: kidong.kim.md[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 174
• Est. completion date: May 31, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Disease
• Incisional Hernia

Intervention

Device:
• Barbed PDS suture (STRATAFIX Symmetric PDS Plus)
STRATAFIX Symmetric PDS Plus is a barbed suture.
• Non-barbed PDS suture (PDS Plus)
Non-barbed suture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of incisional hernia	Incisional hernia till 1 year after surgery	from surgery to 1 year
Secondary	Time-event curve of incisional hernia		from surgery to 1 year
Secondary	Cumulative incidence of surgical site infection		from surgery to 4weeks
Secondary	Incidence of wound dehiscence		post-surgery 4weeks
Secondary	Brief Pain Inventory - Korean (BPI-K) score	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
Secondary	Treatment related adverse event		from surgery to 1 year
Secondary	NRS	pain captured by NRS in nursing record, 0-10, higher score means more pain	from surgery to postoperative 4 day