Barbed Suture for Hysterotomy Closure During Cesarean Section

Hysterotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622267
• Other study ID #: GCO 20-2571
• Status: Completed
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: January 8, 2024

Study information

• Verified date: January 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: January 8, 2024
• Est. primary completion date: January 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Hysterotomy

Intervention

Device:
• Barbed suture
to close a C-section incision

Procedure:
• Standard antimicrobial suture
to close a C-section incision

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative blood loss	Quantification of blood loss (QBL)	Day 1, At delivery
Secondary	Time for hysterotomy closure	Time for hysterotomy closure	Day 1, At delivery
Secondary	Number of participants who need additional hemostatic sutures		Day 1, At delivery
Secondary	Number of hemostatic sutures	Number of hemostatic sutures needed during procedure	Day 1, At delivery
Secondary	Rate of Surgical Site Infections (SSI)	Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)	Day 1, At delivery
Secondary	Rate of Surgical Site Infections (SSI)	Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)	6 weeks
Secondary	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