NCT01867567CompletedNot Applicable
Early Bandage Removal Post-Cesarean Delivery
Ziv Hospital2 sites in 1 country320 target enrollmentStarted: August 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 320
- Locations
- 2
- Primary Endpoint
- Wound Disruption
Study Overview
Brief Summary
Women undergoing their first second or third cesarean section will be randomized into two groups. One group will have the abdominal bandage removed at 6 hours post-surgery and the other group will have the bandage removed at 24 hours. Staple removal will be at 5 - 7 days for both groups. The incision will be inspected at the time of staple removal. The 2 groups will be compared for incision disruption and infection. Also, the women will be asked about their satisfaction for time of bandage removal.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age of 18 to 44
- •elective cesarean section, primary or repeat
- •low risk pregnancy
Exclusion Criteria
- •under the age of 18 and above the age of 44
- •diabetes, preeclampsia or other pregnancy complications
- •unable or unwilling to give informed consent
- •chorioamnionitis
- •BMI over 35
- •more than 3 cesareans
Arms & Interventions
6 Hours
Experimental
Removal of bandage after 6 hours
Intervention: abdominal bandage (Procedure)
24 hours
Active Comparator
removal of bandage after 24 hours
Intervention: abdominal bandage (Procedure)
Outcomes
Primary Outcomes
Wound Disruption
Time Frame: 5 - 7 days
Secondary Outcomes
- Patient satisfaction(5 - 7 days)
- Wound Infection(5 - 7 days)
Investigators
David Peleg
Staff Physician
Ziv Hospital
Study Sites (2)
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