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NCT03386240 · ClinicalTrials.gov registry record · Phase 4
Antibacterial-coated Sutures at Time of Cesarean
A Phase 4 study, sponsored by The University of Texas Medical Branch, Galveston.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1,169
- Enrollment target
NCT03386240: Clinical Trial Phase 4 study, sponsored by The University of Texas Medical Branch, Galveston.
NCT03386240 is a Phase 4 study that was terminated before completion, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 1,169 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03386240, a Phase 4 study, was terminated before completion, sponsored by The University of Texas Medical Branch, Galveston.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1,169 participants
- Enrollment target
Study Summary
Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (SSI) after cesarean delivery.
Primary Outcome
Number of Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections post-cesarean infections occurring within 30 days of delivery, including endometritis, wound infection, or other infections. Endometritis: Presence of two or more of the following signs with no other identified etiology: fever (\>38°C or \>100.4°F), abdominal pain, fundal tenderness, or cervical/vaginal purulent discharge. Wound Infection: Presence of superficial or deep incisional surgical site infectio
Interventions
- DRUG Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)
- OTHER Vicryl, monocryl, PDS (not coated with triclosan)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,169 participants |
| Start Date | 2018-01-09 |
| Est. Completion | 2024-11-22 |
| Phase | Phase 4 |
Why NCT03386240 stopped before completion
NCT03386240 is an interventional study that assigns participants to a tested intervention. Its 1,169 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (126% higher).
The record links to 0 conditions, and to 2 interventions - of which Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures) is the first listed.
NCT03386240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03386240 about?
NCT03386240 is a clinical study titled "Antibacterial-coated Sutures at Time of Cesarean". Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (...
What is the current status of trial NCT03386240?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1,169 participants. The study started on 2018-01-09. Estimated completion is 2024-11-22.
What interventions are being tested in trial NCT03386240?
The interventions under investigation include: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures) (DRUG), Vicryl, monocryl, PDS (not coated with triclosan) (OTHER).
Who is sponsoring clinical trial NCT03386240?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03386240's enrollment target sits among peer trials
1,169 63rd of 2000 higher than 1,938 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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