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
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 20, 2008
Results First Received: June 4, 2010
Last Updated: June 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Healthpoint:
wound healing
scarring
collagenase
Santyl

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014