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

May 2, 2018 updated by: Wolfson Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel
        • Wolfson Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: POD4
REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 4
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
Other: POD8
REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 8
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Investigators

  • Principal Investigator: Hadas Miremberg, MD, Wolfson Medical Center- Tel Aviv University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

October 30, 2017

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 23, 2017

First Posted (Actual)

February 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 0150-16- WOMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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