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

University Hospital Schleswig-Holstein (UKSH)

Status: Unknown

Conditions: Keloid; Cicatrix, Hypertrophic

Treatments: Drug: Silicone gel (Dermatix®)

Study type: Interventional

Funder types: Other

Identifiers

NCT00565552

Dermatix01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Active Comparator group

Description:

Each patient uses the silicone gel on one half of the scar, leaving the other one blank as an internal control.

Treatment:

Drug: Silicone gel (Dermatix®)