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Effect of Collagenase on Healing and Scarring

This study has been completed.
Sponsor:
Information provided by:
Healthpoint
ClinicalTrials.gov Identifier:
NCT00651820
First received: March 20, 2008
Last updated: June 7, 2011
Last verified: June 2011

March 20, 2008
June 7, 2011
April 2008
November 2009   (final data collection date for primary outcome measure)
Time to Complete Wound Closure Collagenase Santyl and Vehicle [ Time Frame: 21 days ] [ Designated as safety issue: No ]
complete wound closure [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00651820 on ClinicalTrials.gov Archive Site
Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements.
Not Provided
Not Provided
Not Provided
 
Effect of Collagenase on Healing and Scarring
A Randomized, Double-blind, Paired-Comparison of the Effect of Collagenase Santyl® Ointment on Healing and Scarring Characteristics of 600μm Dermatome Wounds

A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment versus vehicle alone.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Scarring
  • Impaired Wound Healing
  • Drug: Collagenase Santyl

    Dermatome-induced skin wounds treated with drug active.

    Each subject serves as his own control receiving both treatments in parallel.

  • Drug: Collagenase Santyl Vehicle
    Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.
  • Experimental: Collagenase Santyl Rate of Wound Closure
    Dermatome-induced skin wounds treated with drug active (collagenase).
    Intervention: Drug: Collagenase Santyl
  • Placebo Comparator: Vehicle Rate of Wound Closure
    Dermatome-induced skin wounds treated with Vehicle alone.
    Intervention: Drug: Collagenase Santyl Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
March 2010
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Provide written informed consent
  2. Willing to attend all required study visits

Exclusion Criteria:

  1. Known hypersensitivity to Clostridial collagenase
  2. Anticoagulants (blood thinners, including aspirin) within two weeks
  3. Congenital skin disorder which affects keratinocytes, elastin, or collagen
  4. Any dermatologic disease which may be aggravated or provoked by the wounding procedure
  5. Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding
  6. At risk of keloid or hypertrophic scar formation
  7. Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed
  8. Any skin disorder which causes delayed healing
  9. Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome
  10. Taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00651820
017 101 09 001
No
Shai M. Rozen, MD, University of Texas Southwestern Medical Center
Healthpoint
Not Provided
Study Director: Herbert B Slade, MD Healthpoint
Healthpoint
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP