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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00565552

Enrollment

Registered

2007-11-30

Start date

2007-01-31

Completion date

2009-01-31

Last updated

2007-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cicatrix, Hypertrophic, Keloid

Keywords

silicone gel, cicatrix, wound healing, scar, keloid

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.

Interventions

DRUGSilicone 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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

9 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.)	45 minutes

Secondary

Measure	Time frame
allergic reaction compliance	retrospective

Countries

Germany

Contacts

Primary ContactStefan Nitsch, MD

stefan.nitsch@hno.uni.luebeck.de+49 451 500

Backup ContactHenning Frenzel, MD

henning.frenzel@hno.uni-luebeck.de+49 451 500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026