NCT03386240

Antibacterial-coated Sutures at Time of Cesarean

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,122 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A review of 18 studies demonstrated a significant benefit of antimicrobial coated sutures in reducing SSI (RCTs: OR 0.72; 95% CI 0.59-0.88; observational studies: OR 0.58; 95% CI 0.40-0.83). As there are no clinical trials focusing on cesarean delivery, and because the risk factors and pathogenesis for post-cesarean SSI may not mirror other procedures, further data is needed before generalizing the WHO recommendations to cesarean procedures.

Conditions

• Surgical Site Infection
• Surgical Wound Infection
• Cesarean Section; Infection
• Cesarean Section Complications

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-09
• Primary completion: 2024-11-22
• Completion: 2024-11-22
• First posted: 2017-12-29
• Last updated: 2025-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study