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

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00565552
• Other study ID #: Dermatix01
• Status: Recruiting
• Phase: N/A
• First received: November 29, 2007
• Last updated: November 29, 2007
• Start date: January 2007
• Est. completion date: January 2009

Study information

• Verified date: November 2007
• Source: University of Schleswig-Holstein
• Contact: Stefan Nitsch, MD
• Phone: +49 451 500
• Email: stefan.nitsch[@]hno.uni.luebeck.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix
• Cicatrix, Hypertrophic
• Keloid

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein	Luebeck

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.)		45 minutes	No
Secondary	allergic reaction compliance		retrospective	No