Antibacterial-coated Sutures at Time of Cesarean
Purpose
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.
Conditions
- Surgical Site Infection
- Surgical Wound Infection
- Cesarean Section; Infection
- Cesarean Section Complications
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Double-blinded controlled clinical trial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Placebo Comparator 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. |
|
Recruiting Locations
Galveston, Texas 77550
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Medical Branch, Galveston
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.