N/A
N=301
Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section
Pregnancy · Obese
Bottom Line
View on ClinicalTrials.gov: NCT01826604 ↗Enrolled (actual)
301
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Wound Infection or Disruption — 38; 37 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alexis O C-Section Retractor (Device); Control- Conventional retractors (Other)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- Female
- Sponsor
- St. Louis University
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Infection or Disruption |
38; 37 | — |
| SECONDARY Secondary Outcomes Will Include the Differences Between the Two Groups. |
20; 19; 14; 13; 6; 6 | — |
Summary
The purpose of this study is to investigate the effects of the Alexis O C-section retractor in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections. Patients will be randomized to the use of the Alexis retractor during Cesarean section (treatment group) or the use of traditional hand-held retractors (control group). We will determine if there is any difference in surgical site infection or wound disruption rates. We will also determine if there is a difference in the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length of stay, intra-operative or postoperative anti-emetic requirements, need for hospital readmission or emergency room visits, or other complication rate between the two groups.
Eligibility Criteria
Inclusion Criteria
- Pregnant women
- BMI greater than or equal to 30 kg/m squared
- Aged 14-50 years old
- Undergoing non-emergent cesarean section for delivery
Exclusion Criteria
- Subjects undergoing emergency Cesarean-section
- Pre-existing concurrent infection other than chorioamnionitis
- State of immunosuppression (ie. HIV, cancer)
- Long-term steroid use (>2 days)
- Subjects with a BMI <30 kg/m2
Data sourced from ClinicalTrials.gov (NCT01826604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.