Barbed Suture for Hysterotomy Closure During Cesarean Section

NCT04622267 | Completed Results FDA Device

• 1 other identifier: GCO 20-2571
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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

Conditions

Hysterotomy

Keywords

Barbed suture; Blood loss; Hysterotomy; Cesarean section

Outcome Measures

Primary Outcomes (1)

• Quantitative Blood Loss

  Quantification of blood loss (QBL)

  Day 1, At delivery

Secondary Outcomes (6)

• Time for Hysterotomy Closure

  Day 1, At delivery

• Number of Participants Who Need Additional Hemostatic Sutures

  Day 1, At delivery

• Number of Hemostatic Sutures

  Day 1, At delivery

• Number of Participants With Surgical Site Infections (SSI)

  Day 1, At delivery

• Rate of Surgical Site Infections (SSI)

  6 weeks

Study Arms (2)

Standard suture

ACTIVE COMPARATOR

Standard antimicrobial suture (vicryl) - control arm

Procedure: Standard antimicrobial suture

Barbed suture

EXPERIMENTAL

Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue

Device: Barbed suture

Interventions

Barbed suture DEVICE

to close a C-section incision

Also known as: STRATAFIX Symmetric PDS Plus Knotless Tissue

Barbed suture

Standard antimicrobial suture PROCEDURE

to close a C-section incision

Also known as: vicryl

Standard suture

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Pregnant women are the only subjects eligible for this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All patients undergoing a scheduled primary cesarean section at Mount Sinai Hospital
• age 18-64.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

• 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/

  PMID: 23596641 BACKGROUND

• Greenberg 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.

  PMID: 24920976 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Polyglactin 910

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyesters; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Nicola Tavella
• Organization: Icahn School of Medicine at Mount Sinai

nicola.tavella@mssm.edu

212-241-3888

Study Officials

• Calvin Lambert, MD

  Icahn School of Medicine at Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-MSH/MSQ/QHC/SSVS/ELM OBGYN FACULTY - ISM

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 9, 2020
• Study Start: July 21, 2021
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)