Barbed Suture for Hysterotomy Closure During Cesarean Section

Study Overview
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Brief Summary
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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
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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.

Official Title
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Barbed Suture: A Look at Its Use for Hysterotomy Closure During Cesarean Section

Conditions
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Hysterotomy

Intervention / Treatment
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* Device: Barbed suture
* Procedure: Standard antimicrobial suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing a scheduled primary cesarean section at Mount Sinai Hospital age 18-64. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard suture<br>Standard antimicrobial suture (vicryl) - control arm | Procedure: Standard antimicrobial suture<br>* to close a C-section incision<br>* Other names: vicryl;|
| Experimental: Barbed suture<br>Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue | Device: Barbed suture<br>* to close a C-section incision<br>* Other names: STRATAFIX Symmetric PDS Plus Knotless Tissue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative blood loss | Quantification of blood loss (QBL) | Day 1, At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for hysterotomy closure | Time for hysterotomy closure | Day 1, At delivery | 
| Number of participants who need additional hemostatic sutures |  | Day 1, At delivery | 
| Number of hemostatic sutures | Number of hemostatic sutures needed during procedure | Day 1, At delivery | 
| Rate of Surgical Site Infections (SSI) | Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis) | Day 1, At delivery | 
| Rate of Surgical Site Infections (SSI) | Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis) | 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 assesment by a telephone screening 2 weeks following delivery. | Day 1, At delivery and 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barbed suture, Blood loss, Hysterotomy, Cesarean section