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Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage
This study is currently recruiting participants.
Study NCT00565552   Information provided by University of Schleswig-Holstein
First Received: November 29, 2007   No Changes Posted

November 29, 2007
November 29, 2007
January 2007
 
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 ]
Same as current
No Changes Posted
allergic reaction compliance [ Time Frame: retrospective ] [ Designated as safety issue: No ]
Same as current
 
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

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.

 
 
Interventional
Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
  • Cicatrix, Hypertrophic
  • Keloid
Drug: Silicone gel (Dermatix®)
Active Comparator: Each patient uses the silicone gel on one half of the scar, leaving the other one blank as an internal control.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
January 2009
 

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
Both
9 Years and older
No
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
Germany
 
NCT00565552
Dr. Stefan Nitsch, University of Schleswig-Holstein
Dermatix01
University of Schleswig-Holstein
 
Principal Investigator: Stefan Nitsch, MD University Hospital Schleswig-Holstein - Kiel Campus
University of Schleswig-Holstein
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP