Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage
Not Applicable
- Conditions
- Cicatrix, HypertrophicKeloid
- Interventions
- Drug: Silicone gel (Dermatix®)
- Registration Number
- NCT00565552
- Lead Sponsor
- University Hospital Schleswig-Holstein
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Silicone gel (Dermatix®) Each patient uses the silicone gel on one half of the scar, leaving the other one blank as an internal control.
- Primary Outcome Measures
Name Time Method Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.) 45 minutes
- Secondary Outcome Measures
Name Time Method allergic reaction compliance retrospective
Trial Locations
- Locations (1)
University Hospital Schleswig-Holstein
🇩🇪Luebeck, Germany