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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Steri3X
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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. | Other: Control<br>* Device: Steri3X This study will initially attempt to recruit pregnant patients at the Regional One Health outpatient obstetrics clinic, at which point they will be randomly assigned to one of two cohorts. Participants who are consented to participate in the study will receive a chart flag in the EMR so that they may receive the proper intraoperative and postoperative treatment(s). Patients randomized to receive the control wound dressing will have the current standard of care dressing applied in the operating room after closure of the Cesarean section incision. Participants of both arms will be monitored postoperatively to assess for signs and symptoms of postoperative surgical site infection(s).<br>|
| Experimental: Experimental<br>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. | Device: Steri3X<br>* This study will initially attempt to recruit pregnant patients at the Regional One Health outpatient obstetrics clinic, at which point they will be randomly assigned to one of two cohorts. Participants who are consented to participate in the study will receive a chart flag in the EMR so that they may receive the proper intraoperative and postoperative treatment(s). Patients randomized to receive the Steri3X wound dressing will have the liquid polymer applied in the operating room after closure of the Cesarean section incision. Participants of both arms will be monitored postoperatively to assess for signs and symptoms of postoperative surgical site infection(s).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection | Postoperative patients will be monitored for signs/symptoms of infection after Cesarean section during their inpatient postoperative stay and also during postpartum office visits. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine infection, cesarean, postpartum endometritis, surgical site infection, postoperative wound infection