Barbed Suture for Hysterotomy Closure During Cesarean Section

October 14, 2024 updated by: Calvin Lambert, Icahn School of Medicine at Mount Sinai

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 :

  1. Randomization to barbed suture vs. standard suture
  2. Collection of data for primary and secondary outcomes
  3. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Blood Loss
Time Frame: Day 1, At delivery
Quantification of blood loss (QBL)
Day 1, At delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Surgical Site Infections (SSI)
Time Frame: 6 weeks
Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)
6 weeks
Time for Hysterotomy Closure
Time Frame: Day 1, At delivery
Time for hysterotomy closure
Day 1, At delivery
Number of Participants Who Need Additional Hemostatic Sutures
Time Frame: Day 1, At delivery
Day 1, At delivery
Number of Hemostatic Sutures
Time Frame: Day 1, At delivery
Number of hemostatic sutures needed during procedure
Day 1, At delivery
Number of Participants With Surgical Site Infections (SSI)
Time Frame: Day 1, At delivery
Number of Participants to assess rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)
Day 1, At delivery
Change in Pain Score
Time Frame: Day 1, At delivery and 2 weeks

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.
Day 1, At delivery and 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Calvin Lambert, MD, Icahn School of Medicine at Mount Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2021

Primary Completion (Actual)

January 8, 2024

Study Completion (Actual)

January 8, 2024

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 20-2571

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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