We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Collagenase on Healing and Scarring

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00651820
First Posted: April 3, 2008
Last Update Posted: June 9, 2011
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:
Healthpoint
  Purpose
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.

Condition Intervention Phase
Scarring Impaired Wound Healing Drug: Collagenase Santyl Drug: Collagenase Santyl Vehicle Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Paired-Comparison of the Effect of Collagenase Santyl® Ointment on Healing and Scarring Characteristics of 600μm Dermatome Wounds

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Time to Complete Wound Closure Collagenase Santyl and Vehicle [ Time Frame: 21 days ]

Secondary Outcome Measures:
  • Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle [ Time Frame: 9 Months ]
    Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements.


Enrollment: 28
Study Start Date: April 2008
Study Completion Date: March 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Collagenase Santyl Rate of Wound Closure
Dermatome-induced skin wounds treated with drug active (collagenase).
Drug: Collagenase Santyl

Dermatome-induced skin wounds treated with drug active.

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

Placebo Comparator: Vehicle Rate of Wound Closure
Dermatome-induced skin wounds treated with Vehicle alone.
Drug: Collagenase Santyl Vehicle
Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.

  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:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  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): NCT00651820


Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Sponsors and Collaborators
Healthpoint
Investigators
Study Director: Herbert B Slade, MD Healthpoint
  More Information

Responsible Party: Shai M. Rozen, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00651820     History of Changes
Other Study ID Numbers: 017 101 09 001
First Submitted: March 20, 2008
First Posted: April 3, 2008
Results First Submitted: June 4, 2010
Results First Posted: January 26, 2011
Last Update Posted: June 9, 2011
Last Verified: June 2011

Keywords provided by Healthpoint:
wound healing
scarring
collagenase
Santyl

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes