Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial. (ROCD)

Wolfson Medical Center (WMC)

Status: Completed

Conditions: Cesarean Section; Wound, Infection (Following Delivery)

Treatments: Other: Removal of surgical clips at day 4 post operative vs day 8 post operative; Procedure: Elective cesarean delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT03063853

0150-16- WOMC

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 104 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

POD4

Other group

Description:

REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 4

Treatment:

Other: Removal of surgical clips at day 4 post operative vs day 8 post operative

Procedure: Elective cesarean delivery

POD8

Other group

Description:

REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 8

Treatment:

Other: Removal of surgical clips at day 4 post operative vs day 8 post operative

Procedure: Elective cesarean delivery