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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POD4 | Other | REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 4 |
|
| POD8 | Other | REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Removal of surgical clips at day 4 post operative vs day 8 post operative | Other | Removal of surgical clips at day 4 post operative vs day 8 post operative |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) scores. | 8 weeks postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| complications of surgical site infection (SSI) or wound disruption (hematoma or seroma). | 8 weeks postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadas Miremberg, MD | Wolfson Medical Center- Tel Aviv University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfson medical center | Holon | Israel |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007239 | Infections |
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| Elective cesarean delivery | Procedure | non emergent elective cesarean delivery |
|