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
Results First Received: June 4, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Scarring
Impaired Wound Healing
Interventions: Drug: Collagenase Santyl
Drug: Collagenase Santyl Vehicle

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Rate of Wound Closure Collagenase Santyl vs. Vehicle Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.

Participant Flow:   Overall Study
    Rate of Wound Closure Collagenase Santyl vs. Vehicle  
STARTED     28  
COMPLETED     26  
NOT COMPLETED     2  
Lost to Follow-up                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Rate of Wound Closure Collagenase Santyl vs. Vehicle Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.

Baseline Measures
    Rate of Wound Closure Collagenase Santyl vs. Vehicle  
Number of Participants  
[units: participants]
  28  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     28  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  37.6  ± 8.2  
Gender  
[units: participants]
 
Female     18  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     28  



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

2.  Secondary:   Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle   [ Time Frame: 9 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Herbert B. Slade, M.D., FAAAI
Organization: Healthpoint, Ltd.
phone: 817-900-4000
e-mail: bert.slade@healthpoint.com


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