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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
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecologic Disease

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept 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

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

    First Posted
    November 11, 2020
    Last Updated
    November 23, 2020
    Sponsor
    Seoul National University Hospital
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    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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