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

A Long Term Follow-Up to Study 017-101-09-001: Effect of Collagenase Santyl® Ointment vs. Placebo on Healing and Scarring Characteristics of 600um Dermatome Wounds

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.

Study Overview

• Status: Completed
• Conditions: Follow up to Acute Wound Scar Study
• Intervention / Treatment: Biological: Santyl

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy adult volunteers who were previously treated in study 017-101-09-001 with Collagenase Santyl Ointment and Vehicle (white petrolatum ointment).

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Assessment; All subjects will receive same assessments.	Biological: Santyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar Assessment	Vancouver Scar Scale assessment of dermatome wounds previously treated with Santyl Ointment or White Petrolatum	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar Quality	Quality of scars over time will be assessed with the BTC-2000 instrument assessment	1 Day

Collaborators and Investigators

• Sponsor: Healthpoint
• Investigators: Principal Investigator: Shai Rozen, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: October 9, 2012
• First Submitted That Met QC Criteria: October 11, 2012
• First Posted (Estimate): October 12, 2012

Study Record Updates

• Last Update Posted (Estimate): April 15, 2013
• Last Update Submitted That Met QC Criteria: April 11, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Collagen, collagenase, scar
• Other Study ID Numbers: 017-101-09-032