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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2007 by University of Schleswig-Holstein. Recruitment status was Recruiting

First Received on November 29, 2007. No Changes Posted

Sponsor:	University of Schleswig-Holstein
Information provided by:	University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT00565552

Purpose

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.

Condition	Intervention
Cicatrix, Hypertrophic Keloid	Drug: Silicone gel (Dermatix®)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage for Standardised Total Ear Reconstruction

Resource links provided by NLM:

MedlinePlus related topics: Scars

Drug Information available for: Silicone

U.S. FDA Resources

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:

Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.) [ Time Frame: 45 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

allergic reaction compliance [ Time Frame: retrospective ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2007
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
Active Comparator: 1 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®) 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. Other Name: Dermatix®

Eligibility

Ages Eligible for Study:	9 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565552

Contacts

Contact: Stefan Nitsch, MD	+49 451 500 ext 2244	stefan.nitsch@hno.uni.luebeck.de
Contact: Henning Frenzel, MD	+49 451 500 ext 2244	henning.frenzel@hno.uni-luebeck.de

Locations

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

Sponsors and Collaborators

University of Schleswig-Holstein

Investigators

Principal Investigator:

Stefan Nitsch, MD

University of Schleswig-Holstein

More Information

No publications provided

Responsible Party:	Dr. Stefan Nitsch, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT00565552 History of Changes
Other Study ID Numbers:	Dermatix01
Study First Received:	November 29, 2007
Last Updated:	November 29, 2007
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:

silicone gel
cicatrix
wound healing
scar
keloid

Additional relevant MeSH terms:

Hypertrophy
Keloid
Cicatrix, Hypertrophic
Cicatrix
Pathological Conditions, Anatomical

Collagen Diseases
Connective Tissue Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on February 13, 2012