Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage

November 29, 2007 updated by: University Hospital Schleswig-Holstein

Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage for Standardised Total Ear Reconstruction

So far the evaluation of scar treatment was based on subjective criteria. The patient groups were divided into treated versus non-treated.

In this study we use patients undergoing ear reconstruction with autologous rib cartilage. The thoracic scar of harvesting the rib cartilage is routinely reopened after 3 month during second stage of reconstruction. Therefore we have a ideal model of clinical, physiological and histological scar evaluation in a homologous patient group.

All patients randomly treat one half of the scar with a silicone gel (Dermatix). The other half is untreated as an internal control.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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

  • Germany
      • Luebeck, Germany, 23564
        • Recruiting
        • University Hospital Schleswig-Holstein

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

9 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with high grade microtia requiring a reconstruction with autologous rib cartilage

Exclusion Criteria:

  • diabetes mellitus
  • vascular disease
  • known allergic reaction to silicone

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Each patient uses the silicone gel on one half of the scar, leaving the other one blank as an internal control.
Drug: Silicone gel (Dermatix®)
The half one the scar to treat was randomised among patients. After regular cleaning of the skin around the scar one half was thinly creamed with the silicone gel from medial to lateral and let dry for 5 minutes. It was done twice daily.
Other Names:
  • Dermatix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.)
Time Frame: 45 minutes
45 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
allergic reaction compliance
Time Frame: retrospective
retrospective

Collaborators and Investigators

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

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Stefan Nitsch, MD, University Hospital Schleswig-Holstein

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, 2007

Study Completion (Anticipated)

January 1, 2009

Study Registration Dates

First Submitted

November 29, 2007

First Submitted That Met QC Criteria

November 29, 2007

First Posted (Estimate)

November 30, 2007

Study Record Updates

Last Update Posted (Estimate)

November 30, 2007

Last Update Submitted That Met QC Criteria

November 29, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dermatix01

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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