N/A
N=226
Barbed Suture for Hysterotomy Closure During Cesarean Section
Hysterotomy
Bottom Line
View on ClinicalTrials.gov: NCT04622267 ↗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
| Outcome | Result | p-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
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.