Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.

Study Overview
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Brief Summary
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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.

Detailed Description
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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%.

Official Title
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Early Versus Late Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.

Conditions
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Cesarean Section; Wound, Infection (Following Delivery)

Intervention / Treatment
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* Other: Removal of surgical clips at day 4 post operative vs day 8 post operative
* Procedure: Elective cesarean delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: POD4<br>REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 4 | Other: Removal of surgical clips at day 4 post operative vs day 8 post operative<br>* Removal of surgical clips at day 4 post operative vs day 8 post operative<br>Procedure: Elective cesarean delivery<br>* non emergent elective cesarean delivery<br>|
| Other: POD8<br>REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 8 | Other: Removal of surgical clips at day 4 post operative vs day 8 post operative<br>* Removal of surgical clips at day 4 post operative vs day 8 post operative<br>Procedure: Elective cesarean delivery<br>* non emergent elective cesarean delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Observer Scar Assessment Scale (POSAS) scores. |  | 8 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications of surgical site infection (SSI) or wound disruption (hematoma or seroma). |  | 8 weeks postoperative |