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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Each patient uses the silicone gel on one half of the scar, leaving the other one blank as an internal control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicone gel (Dermatix®) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.) | 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| allergic reaction compliance | retrospective |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Nitsch, MD | Contact | +49 451 500 | 2244 | stefan.nitsch@hno.uni.luebeck.de |
| Henning Frenzel, MD | Contact | +49 451 500 | 2244 | henning.frenzel@hno.uni-luebeck.de |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Nitsch, MD | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Schleswig-Holstein | Recruiting | Lübeck | 23564 | Germany |
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| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| D007627 | Keloid |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003095 | Collagen Diseases |
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| ID | Term |
|---|---|
| D020034 | Silicone Gels |
| ID | Term |
|---|---|
| D012828 | Silicones |
| D012833 | Siloxanes |
| D017646 | Organosilicon Compounds |
| D009930 | Organic Chemicals |
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|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |