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

Sponsored by:	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®)

MedlinePlus related topics: Scars

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage for Standardised Total Ear Reconstruction

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
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®) 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.

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 Hospital Schleswig-Holstein - Kiel Campus

More Information

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

Keywords provided by University of Schleswig-Holstein:

silicone gel
cicatrix
wound healing
scar
keloid

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hypertrophy
Cicatrix, Hypertrophic
Skin Diseases

Collagen Diseases
Keloid
Connective Tissue Diseases
Cicatrix

ClinicalTrials.gov processed this record on January 15, 2009