Gynecologic DiseaseBARBHERNCT04643197
Effect of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Diseases (BARBHER)
A study testing Barbed PDS suture (STRATAFIX Symmetric PDS Plus) and Non-barbed PDS suture (PDS Plus) in people with Gynecologic Disease, run by Seoul National University Hospital.
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. Read more about this study
- Who is it for?
- Ages 19 to 85 years, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Barbed PDS suture (STRATAFIX Symmetric PDS Plus) and Non-barbed PDS suture (PDS Plus)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anticipating midline laparotomy for gynecologic diseases
- ECOG performance status 0 - 2
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Disease (BARBHER)
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.
- Conditions
- Gynecologic Disease
- Being tested
- Barbed PDS suture (STRATAFIX Symmetric PDS Plus), Non-barbed PDS suture (PDS Plus)
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barbed PDS suture (STRATAFIX Symmetric PDS Plus)Device
STRATAFIX Symmetric PDS Plus is a barbed suture.
Non-barbed PDS suture (PDS Plus)Device
Non-barbed suture
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Abdominal fascia will be closed with barbed suture. Receives: Device: Barbed PDS suture (STRATAFIX Symmetric PDS Plus) |
| Control | Active comparator | Abdominal fascia will be closed with non-barbed suture. Receives: Device: Non-barbed PDS suture (PDS Plus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of incisional hernia
Incisional hernia till 1 year after surgery
Measured: from surgery to 1 year
Secondary outcomes (6)
Time-event curve of incisional hernia
Measured: from surgery to 1 year
Cumulative incidence of surgical site infection
Measured: from surgery to 4weeks
Incidence of wound dehiscence
Measured: post-surgery 4weeks
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
Measured: Baseline, postoperative day 2, 4
Treatment related adverse event
Measured: from surgery to 1 year
NRS
pain captured by NRS in nursing record, 0-10, higher score means more pain
Measured: from surgery to postoperative 4 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kidong Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643197
- Sponsor's protocol ID
- KGOG 4001
- Acronym
- BARBHER
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee YJ, Kim NK, Kim K, Choi CH, Lee KH, Lee JM, Lee KB, Suh DH, Kim S, Kim MK, Seong SJ, Lim MC. Effect of fascial closure using barbed sutures on incisional hernias in midline laparotomy for gynecological diseases: A multicenter randomized controlled trial (KGOG 4001). PLoS One. 2025 Nov 19;20(11):e0337036. doi: 10.1371/journal.pone.0337036. eCollection 2025.
PubMed 41259380Choi 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.
PubMed 38901293
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Barbed Suture Fascia Closure on Incisional Hernia in Midline Laparotomy for Gynecological Disease (BARBHER)
- ClinicalTrials.gov ID
- NCT04643197
- Acronym / sponsor ID
- BARBHER / KGOG 4001
- Conditions
- Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: Barbed PDS suture (STRATAFIX Symmetric PDS Plus)Abdominal fascia will be closed with barbed suture. |
| Control | Active comparator | Device: Non-barbed PDS suture (PDS Plus)Abdominal fascia will be closed with non-barbed suture. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Anticipating midline laparotomy for gynecologic diseases
- ECOG performance status 0 - 2
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barbed PDS suture (STRATAFIX Symmetric PDS Plus)STRATAFIX Symmetric PDS Plus is a barbed suture. | Device | Experimental arm |
| Non-barbed PDS suture (PDS Plus)Non-barbed suture | Device | Control |
Primary outcome
Cumulative incidence of incisional hernia
Time frame: from surgery to 1 year
Incisional hernia till 1 year after surgery
6 secondary outcomes
Time-event curve of incisional hernia
Time frame: from surgery to 1 year
Cumulative incidence of surgical site infection
Time frame: from surgery to 4weeks
Incidence of wound dehiscence
Time frame: post-surgery 4weeks
Brief Pain Inventory - Korean (BPI-K) score
Time frame: Baseline, postoperative day 2, 4
Treatment related adverse event
Time frame: from surgery to 1 year
NRS
Time frame: from surgery to postoperative 4 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Derived from this study: PubMed 41259380Lee YJ, Kim NK, Kim K, Choi CH, Lee KH, Lee JM, Lee KB, Suh DH, Kim S, Kim MK, Seong SJ, Lim MC. Effect of fascial closure using barbed sutures on incisional hernias in midline laparotomy for gynecological diseases: A multicenter randomized controlled trial (KGOG 4001). PLoS One. 2025 Nov 19;20(11):e0337036. doi: 10.1371/journal.pone.0337036. eCollection 2025.
- Derived from this study: PubMed 38901293Choi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Barbed PDS suture (STRATAFIX Symmetric PDS Plus) and Non-barbed PDS suture (PDS Plus) in people with Gynecologic Disease, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kidong Kim (82 31 787 7262, kidong.kim.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of incisional hernia (time frame: from surgery to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04643197, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.