- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00565552
Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stefan Nitsch, MD
- Phone Number: 2244 +49 451 500
- Email: stefan.nitsch@hno.uni.luebeck.de
Study Contact Backup
- Name: Henning Frenzel, MD
- Phone Number: 2244 +49 451 500
- Email: henning.frenzel@hno.uni-luebeck.de
Study Locations
-
-
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Luebeck, Germany, 23564
- Recruiting
- University Hospital Schleswig-Holstein
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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:
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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
Investigators
- Principal Investigator: Stefan Nitsch, MD, University Hospital Schleswig-Holstein
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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