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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,169
The intervention consists of using Plus group (Triclosan-coated Sutures)
Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
University of Texas Medical Branch in Galveston
Galveston, Texas, United States
Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections
Number of Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections post-cesarean infections occurring within 30 days of delivery, including endometritis, wound infection, or other infections. Endometritis: Presence of two or more of the following signs with no other identified etiology: fever (\>38°C or \>100.4°F), abdominal pain, fundal tenderness, or cervical/vaginal purulent discharge. Wound Infection: Presence of superficial or deep incisional surgical site infection (SSI), including cellulitis/erythema, induration around the incision, or purulent discharge from the incision site with or without fever, including necrotizing fasciitis. Wound hematoma, seroma, or wound breakdown alone without signs of infection was not considered infection. Other Infections: Pelvic septic thrombosis diagnosed based on persistent signs of endometritis with or without radiologic confirmation, or abdominal/pelvic abscess confirmed radiologically.
Time frame: Within 30 days following delivery
Participants With Surgical Site Infection
Number of participants who developed a surgical site infection (SSI) following cesarean delivery.
Time frame: Within 30 days following delivery
Maternal Deaths
Number of Maternal Deaths.
Time frame: Within 30 days following delivery
Participants With Wound Hematoma or Seroma
Number of participants who developed wound hematoma or seroma following cesarean delivery. Wound hematoma was defined as a localized collection of blood at the incision site, and seroma was defined as a localized accumulation of serous fluid at the incision site identified during the postoperative follow-up period.
Time frame: Within 30 days following delivery
Participants With Puerperal Fever
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Number of participants who developed puerperal fever following cesarean delivery. Puerperal fever was defined as a temperature \>100.4°F occurring after the first 24 hours postpartum or a temperature ≥101°F occurring at any time during the postpartum period.
Time frame: Within 30 days following delivery