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

Phase 2

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

• Registration Number: NCT05392400
• Lead Sponsor: University of Tennessee

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-22
• Study First Submitted QC: 2022-05-22
• Study First Posted: 2022-05-26
• Study Start: 2023-02-07
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13
• Primary Completion: 2024-02-07
• Study Completion: 2024-02-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection	8 weeks	Postoperative patients will be monitored for signs/symptoms of infection after Cesarean section during their inpatient postoperative stay and also during postpartum office visits.

Trial Locations

Locations (1)

Regional One Health Medical Center; 🇺🇸 Memphis, Tennessee, United States