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

NCT ID: NCT00565552

Last Updated: 2007-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-01-31

Brief Summary

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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

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Conditions

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Cicatrix, Hypertrophic Keloid

Keywords

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silicone gel cicatrix wound healing scar keloid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Silicone gel (Dermatix®)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Dermatix®

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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University of Schleswig-Holstein

Principal Investigators

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Stefan Nitsch, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

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University Hospital Schleswig-Holstein

Lübeck, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stefan Nitsch, MD

Role: CONTACT

Phone: +49 451 500

Email: [email protected]

Henning Frenzel, MD

Role: CONTACT

Phone: +49 451 500

Email: [email protected]

Other Identifiers

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Dermatix01

Identifier Type: -

Identifier Source: org_study_id