Effect of Collagenase on Healing and Scarring

Completed · Phase 4

Conditions studied: Scarring, Impaired Wound Healing

In brief

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.

Key facts

Study ID

NCT00651820

Run by

Healthpoint

People needed

28

Starts

2008-04-01

Expected to finish

2010-03-01

Last updated by the study team

2011-06-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provide written informed consent
• Willing to attend all required study visits

You may not qualify if…

• 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

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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