The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections

University of Tennessee

Status and phase: Unknown; Phase 2

Conditions: Cesarean Section; Complications, Wound, Infection (Following Delivery); Surgical Site Infection; Postpartum Complication

Treatments: Device: Steri3X; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05392400

22-08663-FB

Details and patient eligibility

About

Postpartum infection if a major cause of maternal morbidity and mortality and surgical site infections are some of the common complications following cesarean section. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital.

Full description

Postpartum infection is a major cause of maternal morbidity and prolonged hospitalization, and places a large burden on the healthcare system with an additional cost of $3,700 (Olsen et al., 2010). Surgical site infection (SSI) is one of the most common post-operative complications following cesarean section, with an incidence of 3-15% worldwide (Zuarez-Eaaston et al., 2017). Wound dressings that are applied after closure of a surgical incision may help healing by providing physical support, protection from external contaminants, and by absorbing exudate (Dumville et al., 2016). A new FDA-approved microbicidial liquid adhesive, Steri3X, has been shown to reduce the incidence of pin-tract infection by 100% in a randomized-controlled trial following external fixation in patients undergoing reconstructive surgery for deformity correction (Pema, 2020). Steri3X is reported to be effective against S. aureus (both MSSA and MRSA), Candida albicans, E. coli, P. aeruginosa, and Candida auris, which are common organisms involved in dermatological infections. The most common organisms responsible for cesarean section SSI include enteric gram negative bacilli, enterococci, and group B streptococcus (Gur et al., 2015). The advantage of this polymer following C-sections is unknown, and a larger study is needed to provide a more robust analysis. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 16 years old or older
• C-section patients only (primary, repeat, or stat)
• Diabetes, obesity ok to include (but not required)
• Patients receiving PCN for GBS prophylaxis ok to include (but not required)
• Application of Steri3X immediately post-op

Exclusion criteria

• Chorioamnionitis or other existing infection excluded (Single maternal fever >39 C, 2 maternal fevers > 38, or clinical risk factors for chorioamnionitis)
• Patients receiving antibiotic treatment for existing or prior infection other than PCN for GBS prophylaxis
• Patients receiving Prevena or other wound vac
• Rupture of membranes >24 hours

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

Control

Active Comparator group

Description:

Currently, the standard of care for Cesarean section patients includes covering the closed incision with a sterile bandage to reduce the chance of infection, and approximately 48 hours of post-op hospitalization and wound surveillance. The "control" group will receive post-operative wound dressings consistent with the current standard of care.

Treatment:

Other: Control

Experimental

Experimental group

Description:

Patients randomized to the Experimental group will receive treatment with Steri3x immediately following closure of the Cesarean section incision. Participants in the experimental group will receive approximately 48 hours of post-op hospitalization and wound surveillance.

Treatment:

Device: Steri3X