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

Cesarean Section; Wound, Infection (Following Delivery) Clinical Trial

— ROCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063853
• Other study ID #: 0150-16- WOMC
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: February 2017
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section; Wound, Infection (Following Delivery)

Intervention

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

Locations

Country	Name	City	State
Israel	Wolfson medical center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient and Observer Scar Assessment Scale (POSAS) scores.		8 weeks postoperative
Secondary	complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).		8 weeks postoperative