Effect of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Diseases (BARBHER) (BARBHER)
Primary Purpose
Gynecologic Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Barbed PDS suture (STRATAFIX Symmetric PDS Plus)
Non-barbed PDS suture (PDS Plus)
Sponsored by
About this trial
This is an interventional treatment trial for Gynecologic Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental arm
Control
Arm Description
Abdominal fascia will be closed with barbed suture.
Abdominal fascia will be closed with non-barbed suture.
Outcomes
Primary Outcome Measures
Cumulative incidence of incisional hernia
Incisional hernia till 1 year after surgery
Secondary Outcome Measures
Time-event curve of incisional hernia
Cumulative incidence of surgical site infection
Incidence of wound dehiscence
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
Treatment related adverse event
NRS
pain captured by NRS in nursing record, 0-10, higher score means more pain
Full Information
NCT ID
NCT04643197
First Posted
November 11, 2020
Last Updated
November 23, 2020
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04643197
Brief Title
Effect of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Diseases (BARBHER)
Acronym
BARBHER
Official Title
Effects of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Disease (BARBHER)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Abdominal fascia will be closed with barbed suture.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Abdominal fascia will be closed with non-barbed suture.
Intervention Type
Device
Intervention Name(s)
Barbed PDS suture (STRATAFIX Symmetric PDS Plus)
Intervention Description
STRATAFIX Symmetric PDS Plus is a barbed suture.
Intervention Type
Device
Intervention Name(s)
Non-barbed PDS suture (PDS Plus)
Intervention Description
Non-barbed suture
Primary Outcome Measure Information:
Title
Cumulative incidence of incisional hernia
Description
Incisional hernia till 1 year after surgery
Time Frame
from surgery to 1 year
Secondary Outcome Measure Information:
Title
Time-event curve of incisional hernia
Time Frame
from surgery to 1 year
Title
Cumulative incidence of surgical site infection
Time Frame
from surgery to 4weeks
Title
Incidence of wound dehiscence
Time Frame
post-surgery 4weeks
Title
Brief Pain Inventory - Korean (BPI-K) score
Description
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
Time Frame
Baseline, postoperative day 2, 4
Title
Treatment related adverse event
Time Frame
from surgery to 1 year
Title
NRS
Description
pain captured by NRS in nursing record, 0-10, higher score means more pain
Time Frame
from surgery to postoperative 4 day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kidong Kim
Phone
82 31 787 7262
Email
kidong.kim.md@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Diseases (BARBHER)
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