Status:
UNKNOWN
The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections
Lead Sponsor:
University of Tennessee
Conditions:
Surgical Site Infection
Cesarean Section; Complications, Wound, Infection (Following Delivery)
Eligibility:
FEMALE
16+ years
Phase:
PHASE2
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...
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). Su...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 7 2024
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05392400
Start Date
February 7 2023
End Date
February 7 2024
Last Update
February 13 2023
Active Locations (1)
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1
Regional One Health Medical Center
Memphis, Tennessee, United States, 38103