Long Term Follow Up to Determine the Effects of Collagenase SANTYL Ointment on Scar Formation

Healthpoint

Status: Completed

Conditions: Follow up to Acute Wound Scar Study

Treatments: Biological: Santyl

Study type: Observational

Funder types: Industry

Identifiers

NCT01705860

017-101-09-032

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

12 participants in 1 patient group

Assessment

Description:

All subjects will receive same assessments.

Treatment:

Biological: Santyl