|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00565552 |
|
Date of registration:
|
29/11/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage
|
|
Scientific title:
|
Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage for Standardised Total Ear Reconstruction |
|
Date of first enrolment:
|
January 2007 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00565552 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Stefan Nitsch, MD |
|
Address:
|
|
|
Telephone:
|
+49 451 500 |
|
Email:
|
stefan.nitsch@hno.uni.luebeck.de |
|
Affiliation:
|
|
|
|
Name:
|
Stefan Nitsch, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Schleswig-Holstein |
| |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
9 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Cicatrix, Hypertrophic
|
|
Keloid
|
|
Intervention(s)
|
|
Drug: Silicone gel (Dermatix®)
|
|
Primary Outcome(s)
|
|
Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.)
[Time Frame: 45 minutes]
|
|
Secondary Outcome(s)
|
|
allergic reaction compliance
[Time Frame: retrospective]
|
|
Secondary ID(s)
|
|
Dermatix01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|