Abdominal Closure Bundle to Reduce Surgical Site Infection in Patients Undergoing C-sections. Cesarean Section Lead to Reduction in Surgical Site Infection? - A Randomized Controlled Trial
Status unconfirmed · Not applicable
Conditions studied: Surgical Site Infection, Cesarean Section; Infection
In brief
This study is a single center, randomized controlled trial investigating the use of an abdominal closure bundle to reduce surgical site infection in patients undergoing cesarean section. The abdominal closure bundle consists of surgeon repeat scrub, changing gown and gloves, as well as usage of new instruments for closure of fascia, subcutaneous tissue, and skin. Patients will be randomized to either abdominal closure bundle or normal operative procedure. Primary outcome is surgical site infection within 30 days of procedure.
Key facts
- Study ID
- NCT03500055
- Run by
- Abington Memorial Hospital
- People needed
- 850
- Starts
- 2018-06-01
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2018-07-05
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 18 years or older
- Greater than 34 weeks of gestation who will be undergoing a scheduled cesarean section to be performed by Abington Primary Women's Health Care Group, Abington Ob/Gyn Associates, Womencare, Women's Health Care Group, Dr. Ron Hoffman, or the Ob/Gyn Chief Service will be considered for participation in this study.
- Patients who present to obstetrical triage in labor or with ruptured membranes who are for cesarean section are also included in the study.
You may not qualify if…
- Unscheduled, STAT or urgent cesarean sections from the labor floor (failure to descend, failure to progress, non-reassuring fetal heart tracing, chorioamnionitis, placental abruption, prolapsed cord, etc.)
- SOAT (Surgical Operative Assist Team) cesarean sections
- Gestational age < 34 weeks for any reason
- Preterm premature rupture of membranes from antepartum unit
Where it is running
- Abington Hospital-Jefferson Health — Abington, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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