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

Completed

• Conditions: Follow up to Acute Wound Scar Study
• Interventions: Biological: Santyl

• Registration Number: NCT01705860
• Lead Sponsor: Healthpoint

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Primary Completion: 2013-02
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-11
• Last Update Posted: 2013-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Assessment	Santyl	All subjects will receive same assessments.

Primary Outcome Measures

Name	Time	Method
Scar Assessment	1 Day	Vancouver Scar Scale assessment of dermatome wounds previously treated with Santyl Ointment or White Petrolatum

Secondary Outcome Measures

Name	Time	Method
Scar Quality	1 Day	Quality of scars over time will be assessed with the BTC-2000 instrument assessment