Antibacterial-coated Sutures at Time of Cesarean

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2024-11-22

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

A confidential computer-generated simple randomization scheme will be prepared and provided on an ongoing basis. A randomization log will be used to track the randomization process. Patients will be masked to the suture material. Both suture types look similar. Patient, surgeons, and staff ascertaining the outcomes will be masked for the suture type.

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

The intervention consists of using Plus group (Triclosan-coated Sutures)

Vicryl, monocryl, PDS (not coated with triclosan)

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

Group Type PLACEBO_COMPARATOR

Vicryl, monocryl, PDS (not coated with triclosan)

Intervention Type OTHER

Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.

Interventions

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

The intervention consists of using Plus group (Triclosan-coated Sutures)

Intervention Type DRUG

Vicryl, monocryl, PDS (not coated with triclosan)

Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.

Intervention Type OTHER

Other Intervention Names

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Plus group Control group

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No