Cesarean Section Complications, Cesarean Section; Infection, Surgical Site Infection, Surgical Wound Infection
Conditions
Brief summary
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
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.
Interventions
DRUGVicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)
The intervention consists of using Plus group (Triclosan-coated Sutures)
OTHERVicryl, monocryl, PDS (not coated with triclosan)
Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention model description
Double-blinded controlled clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections | Within 30 days following delivery | 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. |
| Participants With Surgical Site Infection | Within 30 days following delivery | Number of participants who developed a surgical site infection (SSI) following cesarean delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Deaths | Within 30 days following delivery | Number of Maternal Deaths. |
| Participants With Wound Hematoma or Seroma | Within 30 days following delivery | 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. |
| Participants With Puerperal Fever | Within 30 days following delivery | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Bush, M.D.
University of Texas Medical Branch in Galveston
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1169 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 433 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 172 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 584 participants |
| Sex: Female, Male Female | 585 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 585 | 0 / 584 |
| other Total, other adverse events | 1 / 585 | 0 / 584 |
| serious Total, serious adverse events | 0 / 585 | 0 / 584 |
Outcome results
None listed