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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 29, 2007 | ||||||||
| Last Updated Date | November 29, 2007 | ||||||||
| Start Date ICMJE | January 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
allergic reaction compliance [ Time Frame: retrospective ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage | ||||||||
| Official Title ICMJE | Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage for Standardised Total Ear Reconstruction | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Silicone gel (Dermatix®) | ||||||||
| Study Arms / Comparison Groups | Active Comparator: Each patient uses the silicone gel on one half of the scar, leaving the other one blank as an internal control. | ||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | January 2009 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 9 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00565552 | ||||||||
| Responsible Party | Dr. Stefan Nitsch, University of Schleswig-Holstein | ||||||||
| Study ID Numbers ICMJE | Dermatix01 | ||||||||
| Study Sponsor ICMJE | University of Schleswig-Holstein | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | University of Schleswig-Holstein | ||||||||
| Verification Date | November 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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