Antibacterial-coated Sutures at Time of Cesarean

Study Overview
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Brief Summary
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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
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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.

Official Title
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Antibacterial-coated Sutures at Time of Cesarean

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

Intervention / Treatment
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* Drug: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)
* Other: Vicryl, monocryl, PDS (not coated with triclosan)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blinded controlled clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures<br>Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure. | Drug: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)<br>* The intervention consists of using Plus group (Triclosan-coated Sutures)<br>* Other names: Plus group;|
| Placebo Comparator: Vicryl, monocryl, PDS (not coated with triclosan)<br>Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure. | Other: Vicryl, monocryl, PDS (not coated with triclosan)<br>* Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of endometritis and/or wound infection and/or other post-cesarean infections | surgical site infection after cesarean | occurring within 30 days of delivery |