Status:
COMPLETED
Effect of Collagenase on Healing and Scarring
Lead Sponsor:
Healthpoint
Conditions:
Scarring
Impaired Wound Healing
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Provide written informed consent
- Willing to attend all required study visits
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00651820
Start Date
April 1 2008
End Date
March 1 2010
Last Update
June 9 2011
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States