Suture Versus Glue (Dermabond) Closure During Cesarean Delivery (SVGCS)

July 11, 2016 updated by: Yair Daykan, Meir Medical Center

Intracuticular Sutures Versus Glue (Dermabond) for Skin Closure After Cesarean Delivery

To investigate the effect of intracutaneous suture closure versus Glue (dermabond) closure at cesarean section (CS) on long-term cosmetic and maternal outcome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Women undergoing planned CS were randomized to either intracutaneous suture closure or glue closure using a 1:1 allocation algorithm. Participants and outcome assessors were blinded to group allocation. Scar evaluation was performed after two months.

Primary outcome measures were Patient and Observer Scar Assessment Scale (POSAS) summary scores 2 months after surgery. Secondary outcome measures were, duration of surgery, and development of hematoma, seroma, surgical site infection (SSI) or wound disruption.

Data were analyzed according to the intention to treat principle.

Study Type

Interventional

Enrollment (Anticipated)

100

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, 11125
        • Recruiting
        • Meir Medical Center
        • Contact:

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 to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women between 18 and 45 years
  • Elective cesarian section

Exclusion Criteria:

  • Clinical signs of infection at the time of CS
  • History of keloids and a medical disorder that could affect wound healing
  • Hypersensitivity to any of the suture materials used in the protocol
  • Diabetes mellitus
  • Disorders requiring chronic corticosteroid use or immunosuppression

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MODIFIED VICRYL PLUS
The intra-cuticular layer will closed with with VICRYL PLUS suture
Device: MODIFIED VICRYL PLUS
closing the intra-cuticular layer with MODIFIED VICRYL PLUS suture
Experimental: DERMABOND GLUE
The intra-cuticular layer will closed with with DERMABOND GLUE
Device: DERMABOND GLUE
closing the intra-cuticular layer with Dermabond glue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: 2 month
Subjective scar rating will be performed using the patient component of the POSAS. The POSAS Scale consists of 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale
2 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative complication
Time Frame: 1 month
Development of surgical site infection or wound disruption.
1 month

Collaborators and Investigators

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

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Reut Ohana, Meir Helsinki

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

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 13, 2016

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0062-16-MMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

within 6 m of finishing the study

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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