Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage for Standardised Total Ear Reconstruction|
- Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.) [ Time Frame: 45 minutes ] [ Designated as safety issue: No ]
- allergic reaction compliance [ Time Frame: retrospective ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||January 2009|
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 Name: Dermatix®
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565552
|Contact: Stefan Nitsch, MD||+49 451 500 ext firstname.lastname@example.org|
|Contact: Henning Frenzel, MD||+49 451 500 ext email@example.com|
|University Hospital Schleswig-Holstein||Recruiting|
|Luebeck, Germany, 23564|
|Principal Investigator:||Stefan Nitsch, MD||University of Schleswig-Holstein|