Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.
NCT ID: NCT03063853
Last Updated: 2018-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2017-02-01
2017-10-30
Brief Summary
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A randomized control trial.
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Detailed Description
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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%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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POD4
REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 4
Removal of surgical clips at day 4 post operative vs day 8 post operative
Removal of surgical clips at day 4 post operative vs day 8 post operative
Elective cesarean delivery
non emergent elective cesarean delivery
POD8
REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 8
Removal of surgical clips at day 4 post operative vs day 8 post operative
Removal of surgical clips at day 4 post operative vs day 8 post operative
Elective cesarean delivery
non emergent elective cesarean delivery
Interventions
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Removal of surgical clips at day 4 post operative vs day 8 post operative
Removal of surgical clips at day 4 post operative vs day 8 post operative
Elective cesarean delivery
non emergent elective cesarean delivery
Eligibility Criteria
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Inclusion Criteria
* previous cesarean delivery performed using the Pfannenstiel method
* 36-41 weeks of gestation based on first trimester ultrasound and a viable fetus.
Exclusion Criteria
* clinical signs of infection at the time of CD, uncontrolled
* vunblanaced diabetes mellitus
* history of keloids
18 Years
45 Years
FEMALE
Yes
Sponsors
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Wolfson Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Hadas Miremberg, MD
Role: PRINCIPAL_INVESTIGATOR
Wolfson Medical Center- Tel Aviv University
Locations
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Wolfson medical center
Holon, , Israel
Countries
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Other Identifiers
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0150-16- WOMC
Identifier Type: -
Identifier Source: org_study_id
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