We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by University of Schleswig-Holstein.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00565552
First Posted: November 30, 2007
Last Update Posted: November 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Schleswig-Holstein
  Purpose

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 Intervention
Cicatrix, Hypertrophic Keloid Drug: Silicone gel (Dermatix®)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • 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:
  • allergic reaction compliance [ Time Frame: retrospective ]

Estimated Enrollment: 20
Study Start Date: January 2007
Estimated Study Completion Date: January 2009
Arms Assigned Interventions
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®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years and older   (Child, Adult, Senior)
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
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
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
Germany
University Hospital Schleswig-Holstein Recruiting
Luebeck, Germany, 23564
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Stefan Nitsch, MD University of Schleswig-Holstein
  More Information

Responsible Party: Dr. Stefan Nitsch, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00565552     History of Changes
Other Study ID Numbers: Dermatix01
First Submitted: November 29, 2007
First Posted: November 30, 2007
Last Update Posted: November 30, 2007
Last Verified: November 2007

Keywords provided by University of Schleswig-Holstein:
silicone gel
cicatrix
wound healing
scar
keloid

Additional relevant MeSH terms:
Hypertrophy
Keloid
Cicatrix
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Fibrosis
Pathologic Processes