Antibacterial-coated Sutures at Time of Cesarean

Surgical Site Infection Clinical Trial

— ASTC  

Official title:

Antibacterial-coated Sutures at Time of Cesarean

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03386240
• Other study ID #: 17-0305
• Status: Recruiting
• Phase: Phase 4
• Start date: January 9, 2018
• Est. completion date: January 30, 2024

Study information

• Verified date: March 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: Benjamin Bush, M.D.
• Phone: (409)772-1011
• Email: babush[@]utmb.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3374
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18-50 years of age.

• Women = 24 weeks' viable gestation.

• To undergo cesarean delivery.

Exclusion Criteria:

• Patient unwilling or unable to provide consent.

• No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.

• Immunosuppressed patients: i.e., taking systemic immunosuppressant or steroids (e.g. transplant patients; not including steroids for lung maturity), HIV with CD4<200, or other.

• Decision to use other than suture closure (e.g. secondary wound closure, mesh closure).

• Skin infection.

• Coagulopathy.

• High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery).

• Allergy to Triclosan.

• Incarcerated individuals.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Cesarean Section; Infection
• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Medical Branch in Galveston	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of endometritis and/or wound infection and/or other post-cesarean infections	surgical site infection after cesarean	occurring within 30 days of delivery