Effect of Collagenase on Healing and Scarring
|ClinicalTrials.gov Identifier: NCT00651820|
Recruitment Status : Completed
First Posted : April 3, 2008
Results First Posted : January 26, 2011
Last Update Posted : June 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Scarring Impaired Wound Healing||Drug: Collagenase Santyl Drug: Collagenase Santyl Vehicle||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|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|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||March 2010|
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.
- Time to Complete Wound Closure Collagenase Santyl and Vehicle [ Time Frame: 21 days ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651820
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States|
|Study Director:||Herbert B Slade, MD||Healthpoint|