Antibacterial-coated Sutures at Time of Cesarean (ASTC)

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Cesarean Section Complications; Surgical Site Infection; Cesarean Section; Infection; Surgical Wound Infection

Treatments: Drug: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures); Other: Vicryl, monocryl, PDS (not coated with triclosan)

Study type: Interventional

Funder types: Other

Identifiers

NCT03386240

17-0305

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,122 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,122 participants in 2 patient groups, including a placebo group

Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures

Experimental group

Description:

Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.

Treatment:

Drug: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)

Vicryl, monocryl, PDS (not coated with triclosan)

Placebo Comparator group

Description:

Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.

Treatment:

Other: Vicryl, monocryl, PDS (not coated with triclosan)