Condition(s) treated: Cicatrix, Hypertrophic; Keloid

Intervention: Silicone gel (Dermatix®) (Drug)

Enrollment status: Recruiting

Sponsor: University of Schleswig-Holstein

Principal investigator(s) or official(s):
Stefan Nitsch, MD, Principal Investigator, Affiliation: University Hospital Schleswig-Holstein - Kiel Campus

Overall contact:
Stefan Nitsch, MD, Phone: +49 451 500, Ext: 2244, Email: stefan.nitsch@hno.uni.luebeck.de

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Primary outcome: 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: allergic reaction compliance (Time Frame: retrospective)

Minimum eligible age: 9 Years. Eligible gender(s): Both.

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

Stefan Nitsch, MD, Phone: +49 451 500, Ext: 2244, Email: stefan.nitsch@hno.uni.luebeck.de

University Hospital Schleswig-Holstein, Luebeck 23564, Germany; Recruiting

Start date: January 2007
End date: January 2009
Last updated: November 29, 2007

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