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

Not Applicable

Completed

• Conditions: Cesarean Section; Wound, Infection (Following Delivery)
• Interventions: Other: Removal of surgical clips at day 4 post operative vs day 8 post operative; Procedure: Elective cesarean delivery

• Registration Number: NCT03063853
• Lead Sponsor: Wolfson Medical Center

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 Timeline

• Status Verified: 2017-02
• Study Start: 2017-02-01
• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-02-24
• Primary Completion: 2017-10-30
• Study Completion: 2017-10-30
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POD8	Elective cesarean delivery	REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 8
POD4	Elective cesarean delivery	REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 4
POD4	Removal of surgical clips at day 4 post operative vs day 8 post operative	REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 4
POD8	Removal of surgical clips at day 4 post operative vs day 8 post operative	REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 8

Primary Outcome Measures

Name	Time	Method
Patient and Observer Scar Assessment Scale (POSAS) scores.	8 weeks postoperative

Secondary Outcome Measures

Name	Time	Method
complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).	8 weeks postoperative

Trial Locations

Locations (1)

Wolfson medical center; 🇮🇱 Holon, Israel