Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery

July 11, 2013 updated by: Husslein Heinrich, MD, Klinikum Klagenfurt am Wörthersee
This is a double blinded randomized study investigating if subcutaneous adaption has an impact on cosmetic outcome after Caesarean delivery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

116

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

  • Austria
    • Carinthia
      • Klagenfurt, Carinthia, Austria, 9020
        • Klinikum Klagenfurt Am Woerthersee

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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women undergoing cesarean section for any indication
  • literate in german language

Exclusion Criteria:

  • history of keloids
  • previous transversal suprapubic scars
  • known patient hypersensitivity to any of the suture materials used in the protocol
  • a medical disorder that could affect wound healing (eg, diabetes mellitus, chronic corticosteroid use)

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: wound closure with subcutaneous adaption
Procedure: subcutaneous adaption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective and subjective cosmetic appearance
Time Frame: after 6 months
after 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Surgical site infection and wound breakdown
Time Frame: within 30 days after surgery
within 30 days after surgery
Haematoma
Time Frame: within 5 days after surgery
within 5 days after surgery

Collaborators and Investigators

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

Sponsor

Klinikum Klagenfurt am Wörthersee

Investigators

  • Principal Investigator: Heinrich Husslein, M.D., Klinikum Klagenfurt am Woerthersee and Medical University Vienna

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

March 1, 2012

Study Registration Dates

First Submitted

February 25, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimate)

March 2, 2012

Study Record Updates

Last Update Posted (Estimate)

July 15, 2013

Last Update Submitted That Met QC Criteria

July 11, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A 16/11

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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