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

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ClinicalTrials.gov Identifier: NCT00565552
Recruitment Status : Unknown
Verified November 2007 by University Hospital Schleswig-Holstein.
Recruitment status was:  Recruiting
First Posted : November 30, 2007
Last Update Posted : November 30, 2007
Sponsor:
Information provided by:
University Hospital Schleswig-Holstein

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cicatrix, Hypertrophic Keloid Drug: Silicone gel (Dermatix®) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2007
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  1. Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.) [ Time Frame: 45 minutes ]

Secondary Outcome Measures :
  1. allergic reaction compliance [ Time Frame: retrospective ]

Eligibility Criteria
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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565552


Contacts
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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
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Germany
University Hospital Schleswig-Holstein Recruiting
Luebeck, Germany, 23564
Sponsors and Collaborators
University Hospital Schleswig-Holstein
Investigators
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Principal Investigator: Stefan Nitsch, MD University Hospital Schleswig-Holstein
More Information
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Responsible Party: Dr. Stefan Nitsch, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00565552    
Other Study ID Numbers: Dermatix01
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: November 30, 2007
Last Verified: November 2007
Keywords provided by University Hospital Schleswig-Holstein:
silicone gel
cicatrix
wound healing
scar
keloid
Additional relevant MeSH terms:
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Keloid
Cicatrix
Cicatrix, Hypertrophic
Collagen Diseases
 Connective Tissue Diseases
Fibrosis
Pathologic Processes