Early Versus Late Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Wolfson Medical Center
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Patient and Observer Scar Assessment Scale (POSAS) scores.
Overview
Brief Summary
The optimal choice of skin closure at cesarean delivery has not yet been determined. This study aim to study the wound complications and scar healing after Surgical staples removal at postoperative day 4 and day 8 .
A randomized control trial.
Detailed Description
A randomized controlled trial in which pregnant women undergoing a scheduled Elective cesarean delivery were assigned to skin closure with surgical staples and were randomly assigned to the day of removal of surgical staples. Postoperative day 4 VS. Postoperative day 8 .
Outcome assessors were blinded to group allocation. Scars will be evaluated after 8 weeks. Primary outcome measures is Patient and Observer Scar Assessment Scale (POSAS) scores. Secondary outcome measures are complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).
A group of 104 women is needed in order to achieve a clinically significant effect with a power of 80%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •elective cesarean delivery
- •previous cesarean delivery performed using the Pfannenstiel method
- •36-41 weeks of gestation based on first trimester ultrasound and a viable fetus.
Exclusion Criteria
- •emergency cesarean delivery
- •clinical signs of infection at the time of CD, uncontrolled
- •vunblanaced diabetes mellitus
- •history of keloids
Outcomes
Primary Outcomes
Patient and Observer Scar Assessment Scale (POSAS) scores.
Time Frame: 8 weeks postoperative
Secondary Outcomes
- complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).(8 weeks postoperative)