HysterotomyNCT04622267
Barbed Suture for Hysterotomy Closure During Cesarean Section
A study testing Barbed suture and Standard antimicrobial suture in people with Hysterotomy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a randomized controlled trial. The purpose of this study is to see if patients whose uterine incision (hysterotomy), at the time of scheduled cesarean section, is closed with barbed suture, have less blood loss compared to women whose incision is closed with the standard suture (vicryl). Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterotomy
- What is being tested?
- Barbed suture and Standard antimicrobial suture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2021to 8 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients undergoing a scheduled primary cesarean section at Mount Sinai Hospital
- age 18-64.
Who cannot join
- Multifetal gestations
- Placenta previas
- Pre-term patients
- Patients with prior uterine incisions or a coagulopathy (DIC, Von Willebrands Disease, etc)
- Patients undergoing an unplanned or emergency cesarean section
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Barbed Suture: A Look at Its Use for Hysterotomy Closure During Cesarean Section
This is a randomized controlled trial. The purpose of this study is to see if patients whose uterine incision (hysterotomy), at the time of scheduled cesarean section, is closed with barbed suture, have less blood loss compared to women whose incision is closed with the standard suture (vicryl). The primary outcome is quantification of blood loss (QBL). Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery.
Study participation will last 1 year and will include the following research procedures :
- Randomization to barbed suture vs. standard suture
- Collection of data for primary and secondary outcomes
- Telephone survey 2 weeks following the procedure to assess pain, bowel/bladder habits, and evidence of wound infection. The barbed suture is approved by the FDA for use in soft tissue approximation and this is not an off-label usage.
Read the detailed description
This is a prospective, randomized controlled trial (RCT) evaluating whether using a barbed suture to close a C-section incision can reduce blood loss. Patients undergoing C-section will be randomized with equal allocation to a barbed suture or a standard antimicrobial suture. The primary outcome is quantification of blood loss (QBL). Differences between the groups will be assessed using a 0.05 level Wilcoxon rank-sum test. Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis/SSI (superficial wound infection, deep wound infection, and endometritis) within 6 weeks postpartum, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery.
- Conditions
- Hysterotomy
- Being tested
- Barbed suture, Standard antimicrobial suture
- Keywords
- Barbed suture, Blood loss, Hysterotomy, Cesarean section
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barbed sutureDevice
Also called STRATAFIX Symmetric PDS Plus Knotless Tissue
to close a C-section incision
Standard antimicrobial sutureProcedure or surgery
Also called vicryl
to close a C-section incision
| Study group | Role | What they receive |
|---|---|---|
| Standard suture | Active comparator | Standard antimicrobial suture (vicryl) - control arm Receives: Procedure: Standard antimicrobial suture |
| Barbed suture | Experimental | Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue Receives: Device: Barbed suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Blood Loss
Quantification of blood loss (QBL)
Measured: Day 1, At delivery
Secondary outcomes (6)
Time for Hysterotomy Closure
Time for hysterotomy closure
Measured: Day 1, At delivery
Number of Participants Who Need Additional Hemostatic Sutures
Measured: Day 1, At delivery
Number of Hemostatic Sutures
Number of hemostatic sutures needed during procedure
Measured: Day 1, At delivery
Number of Participants With Surgical Site Infections (SSI)
Number of Participants to assess rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)
Measured: Day 1, At delivery
Rate of Surgical Site Infections (SSI)
Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)
Measured: 6 weeks
Change in Pain Score
Change in pain score at 2 weeks from baseline. Pain score from 0 to 10, with higher score indicating more pain.
Follow up pain assessment by a telephone screening 2 weeks following delivery.
Measured: Day 1, At delivery and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start21 Jul 2021
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HysterotomyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to either the treatment arm or control arm of the study prior to commencement of the cesarean section and following informed consent. Allocation will be concealed to all researchers/providers until this point. The patients will be randomly allocated by block randomization. Generation of random sequence will be done by independent personnel, usually a statistician, who is not going to be involved in the conduct of the RCT. The access to this sequence should be restricted to only a few individuals who absolutely need to have access.
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Calvin Lambert, Icahn School of Medicine at Mount Sinai
- Investigators
- Calvin Lambert, MD, Principal investigator, Icahn School of Medicine at Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622267
- Sponsor's protocol ID
- GCO 20-2571
- Status last verified
- Oct 2024
- First submitted
- 4 Nov 2020
- Last updated
- 5 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2010. 2013 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #149. Available from http://www.ncbi.nlm.nih.gov/books/NBK132428/
PubMed 23596641Greenberg JA, Goldman RH. Barbed suture: a review of the technology and clinical uses in obstetrics and gynecology. Rev Obstet Gynecol. 2013;6(3-4):107-15.
PubMed 24920976
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barbed Suture: A Look at Its Use for Hysterotomy Closure During Cesarean Section
- ClinicalTrials.gov ID
- NCT04622267
- Acronym / sponsor ID
- GCO 20-2571
- Conditions
- Hysterotomy
- Keywords
- Barbed suture, Blood loss, Hysterotomy, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Posted 5 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial. The purpose of this study is to see if patients whose uterine incision (hysterotomy), at the time of scheduled cesarean section, is closed with barbed suture, have less blood loss compared to women whose incision is closed with the standard suture (vicryl). The primary outcome is quantification of blood loss (QBL). Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery.
Study participation will last 1 year and will include the following research procedures :
- Randomization to barbed suture vs. standard suture
- Collection of data for primary and secondary outcomes
- Telephone survey 2 weeks following the procedure to assess pain, bowel/bladder habits, and evidence of wound infection. The barbed suture is approved by the FDA for use in soft tissue approximation and this is not an off-label usage.
Detailed description
This is a prospective, randomized controlled trial (RCT) evaluating whether using a barbed suture to close a C-section incision can reduce blood loss. Patients undergoing C-section will be randomized with equal allocation to a barbed suture or a standard antimicrobial suture. The primary outcome is quantification of blood loss (QBL). Differences between the groups will be assessed using a 0.05 level Wilcoxon rank-sum test. Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis/SSI (superficial wound infection, deep wound infection, and endometritis) within 6 weeks postpartum, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to either the treatment arm or control arm of the study prior to commencement of the cesarean section and following informed consent. Allocation will be concealed to all researchers/providers until this point. The patients will be randomly allocated by block randomization. Generation of random sequence will be done by independent personnel, usually a statistician, who is not going to be involved in the conduct of the RCT. The access to this sequence should be restricted to only a few individuals who absolutely need to have access.
| Arm | Type | Receives |
|---|---|---|
| Standard suture | Active comparator | Procedure: Standard antimicrobial sutureStandard antimicrobial suture (vicryl) - control arm |
| Barbed suture | Experimental | Device: Barbed sutureBarbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All patients undergoing a scheduled primary cesarean section at Mount Sinai Hospital
- age 18-64.
Key exclusion criteria (5 listed)
- Multifetal gestations
- Placenta previas
- Pre-term patients
- Patients with prior uterine incisions or a coagulopathy (DIC, Von Willebrands Disease, etc)
- Patients undergoing an unplanned or emergency cesarean section
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 sutureAlso: STRATAFIX Symmetric PDS Plus Knotless Tissueto close a C-section incision | Device | Barbed suture |
| Standard antimicrobial sutureAlso: vicrylto close a C-section incision | Procedure or surgery | Standard suture |
Primary outcome
Quantitative Blood Loss
Time frame: Day 1, At delivery
Quantification of blood loss (QBL)
6 secondary outcomes
Time for Hysterotomy Closure
Time frame: Day 1, At delivery
Number of Participants Who Need Additional Hemostatic Sutures
Time frame: Day 1, At delivery
Number of Hemostatic Sutures
Time frame: Day 1, At delivery
Number of Participants With Surgical Site Infections (SSI)
Time frame: Day 1, At delivery
Rate of Surgical Site Infections (SSI)
Time frame: 6 weeks
Change in Pain Score
Time frame: Day 1, At delivery and 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23596641Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2010. 2013 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #149. Available from http://www.ncbi.nlm.nih.gov/books/NBK132428/
- Background: PubMed 24920976Greenberg JA, Goldman RH. Barbed suture: a review of the technology and clinical uses in obstetrics and gynecology. Rev Obstet Gynecol. 2013;6(3-4):107-15.
- Individual participant dataSharing planned: No
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High vs. Low Segmental Hysterotomy: Impact on Uterine Wall Defects Post-Cesarean
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Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)
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Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
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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.
Calvin Lambert, MD principal investigator
Icahn School of Medicine at Mount Sinai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barbed suture and Standard antimicrobial suture in people with Hysterotomy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Blood Loss (time frame: Day 1, At delivery). 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 NCT04622267, 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 5 Nov 2024.