Status:
COMPLETED
Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Surgical Wound Infection
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Post cesarean section surgical site infection (SSI) is a common complication that can affect patient recovery and overall outcome. Several approaches have been studied to improve SSI rates such as tim...
Detailed Description
The study design was a randomized controlled study to evaluate wound infection rates in patients undergoing a cesarean delivery. The patients were randomized into two sub- groups; the first group rece...
Eligibility Criteria
Inclusion
- maternal age of at least 18 years
- a gestational age of at least 24 0/7 wks by best obstetric estimate
- a viable gestation
- a non-emergent cesarean delivery
- a planned transverse skin incision
- Deliveries included: primary cesarean for failed induction, maternal request, or other obstetric indications; and repeat cesarean deliveries that were elective or had obstetric indications (such as spontaneous labor in a subject with a term gestation and with history of 2 or more prior cesarean deliveries)
Exclusion
- chorioamnionitis
- chronic corticosteroid therapy
- prior abdominal vertical skin incision scar or planned vertical incision
- history of a prior wound infection or separation
- planned cesarean hysterectomy
- maternal or fetal complications requiring an emergent delivery
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
564 Patients enrolled
Trial Details
Trial ID
NCT03365219
Start Date
October 1 2010
End Date
October 1 2013
Last Update
October 19 2018
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