Antibacterial-coated Sutures at Time of Cesarean
NCT03386240 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1122
Last updated 2025-01-06
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.
Conditions
- Surgical Site Infection
- Surgical Wound Infection
- Cesarean Section; Infection
- Cesarean Section Complications
Interventions
- DRUG
-
Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)
The intervention consists of using Plus group (Triclosan-coated Sutures)
- OTHER
-
Vicryl, monocryl, PDS (not coated with triclosan)
Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
Sponsors & Collaborators
-
The University of Texas Medical Branch, Galveston
lead OTHER
Principal Investigators
-
Benjamin Bush, M.D. · University of Texas Medical Branch in Galveston
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-09
- Primary Completion
- 2024-11-22
- Completion
- 2024-11-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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