Follow up to Acute Wound Scar Study
Conditions
Keywords
Collagen, collagenase, scar
Brief summary
The present study will evaluate the long term effects on scar formation for dermatome-induced skin wounds treated with Collagenase Santyl® Ointment or vehicle (white petrolatum ointment) alone. The previous study, 017-101-09-001, utilized a small, experimental, cutaneous wound to evaluate both time to complete wound closure and quality of the resulting scar when Collagenase Santyl® Ointment was used to treat the wound.
Interventions
BIOLOGICALSantyl
Sponsors
Healthpoint
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects will be considered qualified for enrollment if they participated in the Collagenase Santyl® Ointment Study 017 101-09-001 and provide written informed consent. * The informed consent document must be read, signed, and dated by the suubject before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject. A photocopy of the signed informed consent document must be provided to the subject and the original signed document placed in the subject's chart. * Subject participated in the 017-101-09-001 study and received at least one application of a test article, whether Collagenase Santyl® Ointment or White Petrolatum.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scar Assessment | 1 Day | Vancouver Scar Scale assessment of dermatome wounds previously treated with Santyl Ointment or White Petrolatum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scar Quality | 1 Day | Quality of scars over time will be assessed with the BTC-2000 instrument assessment |
Countries
United States
Outcome results
None listed