NCT03063853

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Wolfson Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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%.

Conditions

• Cesarean Section; Wound, Infection (Following Delivery)

Interventions

Type	Name	Description
OTHER	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
PROCEDURE	Elective cesarean delivery	non emergent elective cesarean delivery

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-10-30
• Completion: 2017-10-30
• First posted: 2017-02-24
• Last updated: 2018-05-08

Locations

1 site across 1 country: Israel