search
Back to results

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
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix, Hypertrophic focused on measuring silicone gel, cicatrix, wound healing, scar, keloid

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 29, 2007
Last Updated
November 29, 2007
Sponsor
University Hospital Schleswig-Holstein
search

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

We'll reach out to this number within 24 hrs