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OpenTrials
Completed

NCT Number: NCT04622267

Barbed Suture 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.

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Key information

Conditions

Hysterotomy Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

barbed suture

Device

to close a C-section incision

Other names: STRATAFIX Symmetric PDS Plus Knotless Tissue

Standard antimicrobial suture

Procedure

to close a C-section incision

Other names: vicryl

Primary outcomes

  1. Quantitative Blood Loss

    Time frame: Day 1, At delivery

    Quantification of blood loss (QBL)

Secondary outcomes

  1. Time for Hysterotomy Closure

    Time frame: Day 1, At delivery

    Time for hysterotomy closure

  2. Number of Participants Who Need Additional Hemostatic Sutures

    Time frame: Day 1, At delivery

  3. Number of Hemostatic Sutures

    Time frame: Day 1, At delivery

    Number of hemostatic sutures needed during procedure

  4. 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)

  5. Rate of Surgical Site Infections (SSI)

    Time frame: 6 weeks

    Rate of SSI (any of superficial wound infection, deep wound infection, and endometritis)

  6. 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2020
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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