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N/A N=226 Randomized Prevention

Barbed Suture for Hysterotomy Closure During Cesarean Section

Hysterotomy

Enrolled (actual)
226
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Quantitative Blood Loss — 641.8; 596.5 mL

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Barbed suture (Device); Standard antimicrobial suture (Procedure)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Icahn School of Medicine at Mount Sinai
Primary completion
Jan 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Quantitative Blood Loss
641.8; 596.5
SECONDARY
Time for Hysterotomy Closure
326.3; 277.9
SECONDARY
Number of Participants Who Need Additional Hemostatic Sutures
50; 67
SECONDARY
Number of Hemostatic Sutures
1.1; 0.9
SECONDARY
Number of Participants With Surgical Site Infections (SSI)
0; 0
SECONDARY
Rate of Surgical Site Infections (SSI)
SECONDARY
Change in Pain Score
3.1; 3.1

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04622267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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