Effect of Collagenase on Healing and Scarring

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Paired-Comparison of the Effect of Collagenase Santyl® Ointment on Healing and Scarring Characteristics of 600μm Dermatome Wounds

Conditions
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Scarring, Impaired Wound Healing

Intervention / Treatment
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* Drug: Collagenase Santyl
* Drug: Collagenase Santyl Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent Willing to attend all required study visits Exclusion Criteria: Known hypersensitivity to Clostridial collagenase Anticoagulants (blood thinners, including aspirin) within two weeks Congenital skin disorder which affects keratinocytes, elastin, or collagen Any dermatologic disease which may be aggravated or provoked by the wounding procedure Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding At risk of keloid or hypertrophic scar formation Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed Any skin disorder which causes delayed healing Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagenase Santyl Rate of Wound Closure<br>Dermatome-induced skin wounds treated with drug active (collagenase). | Drug: Collagenase Santyl<br>* Dermatome-induced skin wounds treated with drug active. Each subject serves as his own control receiving both treatments in parallel.<br>|
| Placebo Comparator: Vehicle Rate of Wound Closure<br>Dermatome-induced skin wounds treated with Vehicle alone. | Drug: Collagenase Santyl Vehicle<br>* Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Complete Wound Closure Collagenase Santyl and Vehicle |  | 21 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing, scarring, collagenase, Santyl