Staples Versus Dermabond for Closure of the Skin After Cesarean Section

December 15, 2010 updated by: Meir Medical Center

Two of the more frequently used options for skin closure following a cesarean delivery include staples or sutures (stitches). Another method of closure is Dermabond- liquid skin adhesive. This method of closure is used less frequently than either staples or sutures.

Few studies have been done regarding whether Dermabond is preferable or affect the outcome of a cesarean section surgery. The aim of our study is to find weather Dermabond haas better result for the closure of cesarean section wounds.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

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
      • Kfar Saba, Israel
        • Meir 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Woman over 18 year Woman having elective caesarean section

Exclusion Criteria:

Age under 18 Woman having an emergency caesarean section

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Woman with previous ceasarean section - staples
Procedure: Dermabond- liquid skin adhesive
Dermabond- liquid skin adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cosmetic objective evaluation of the scar
Time Frame: 6 weeks postoperatively
6 weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
The difference in pain between the two type of closure
Time Frame: 1 and 4 days postoperatively
1 and 4 days postoperatively
The difference in patient satisfaction with the scar result
Time Frame: 6 weeks postoperatively
6 weeks postoperatively

Collaborators and Investigators

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

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Dana Sadeh, MD, MD

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

January 1, 2011

Primary Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 15, 2010

First Posted (Estimate)

December 16, 2010

Study Record Updates

Last Update Posted (Estimate)

December 16, 2010

Last Update Submitted That Met QC Criteria

December 15, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 155-2010

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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