Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage
Primary Purpose
Cicatrix, Hypertrophic, Keloid
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Silicone gel (Dermatix®)
Sponsored by
About this trial
This is an interventional treatment trial for Cicatrix, Hypertrophic focused on measuring silicone gel, cicatrix, wound healing, scar, keloid
Eligibility 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
Sites / Locations
- University Hospital Schleswig-HolsteinRecruiting
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
1
Arm Description
Each patient uses the silicone gel on one half of the scar, leaving the other one blank as an internal control.
Outcomes
Primary Outcome Measures
Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.)
Secondary Outcome Measures
allergic reaction compliance
Full Information
NCT ID
NCT00565552
First Posted
November 29, 2007
Last Updated
November 29, 2007
Sponsor
University Hospital Schleswig-Holstein
1. Study Identification
Unique Protocol Identification Number
NCT00565552
Brief Title
Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage
Official Title
Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage for Standardised Total Ear Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Schleswig-Holstein
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix, Hypertrophic, Keloid
Keywords
silicone gel, cicatrix, wound healing, scar, keloid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Each patient uses the silicone gel on one half of the scar, leaving the other one blank as an internal control.
Intervention Type
Drug
Intervention Name(s)
Silicone gel (Dermatix®)
Other Intervention Name(s)
Dermatix®
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
allergic reaction compliance
Time Frame
retrospective
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Nitsch, MD
Phone
+49 451 500
Ext
2244
Email
stefan.nitsch@hno.uni.luebeck.de
First Name & Middle Initial & Last Name or Official Title & Degree
Henning Frenzel, MD
Phone
+49 451 500
Ext
2244
Email
henning.frenzel@hno.uni-luebeck.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Nitsch, MD
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Schleswig-Holstein
City
Luebeck
ZIP/Postal Code
23564
Country
Germany
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage
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