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

NCT00565552 | Unknown

• 1 other identifier: Dermatix01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cicatrix, Hypertrophic; Keloid

Keywords

silicone gel; cicatrix; wound healing; scar; keloid

Outcome Measures

Primary Outcomes (1)

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

  45 minutes

Secondary Outcomes (1)

• allergic reaction compliance

  retrospective

Study Arms (1)

1

ACTIVE COMPARATOR

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

Drug: Silicone gel (Dermatix®)

Interventions

Silicone gel (Dermatix®) 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.

Also known as: Dermatix®

1

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with high grade microtia requiring a reconstruction with autologous rib cartilage

You may not qualify if:

• diabetes mellitus
• vascular disease
• known allergic reaction to silicone

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University Hospital Schleswig-Holstein

Lübeck, 23564, Germany

RECRUITING

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Keloid; Cicatrix

Interventions

Silicone Gels

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Stefan Nitsch, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Nitsch, MD

CONTACT

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

Henning Frenzel, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: November 30, 2007
• Study Start: January 1, 2007
• Study Completion: January 1, 2009
• Last Updated: November 30, 2007

Record last verified: 2007-11

Locations

DE (1)