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NCT04622267 · ClinicalTrials.gov registry record · NA
Barbed Suture for Hysterotomy Closure During Cesarean Section
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 226
- Enrollment target
NCT04622267 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 226 participants.
The verdict
NCT04622267, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 226 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Barbed suture
- PROCEDURE Standard antimicrobial suture
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2021-07-21 |
| Est. Completion | 2024-01-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04622267
The ClinicalTrials.gov registry entry for NCT04622267 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Barbed suture is the first listed.
NCT04622267 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04622267 about?
NCT04622267 is a clinical study titled "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...
What is the current status of trial NCT04622267?
This trial is currently completed. It is a NA study. The enrollment target is 226 participants. The study started on 2021-07-21. Estimated completion is 2024-01-08.
What interventions are being tested in trial NCT04622267?
The interventions under investigation include: Barbed suture (DEVICE), Standard antimicrobial suture (PROCEDURE).
Who is sponsoring clinical trial NCT04622267?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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