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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01705860
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : April 15, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Follow up to Acute Wound Scar Study Biological: Santyl

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Study Type : Observational
Actual Enrollment : 12 participants
Time Perspective: Prospective
Official Title: 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
Study Start Date : September 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
All subjects will receive same assessments.
Biological: Santyl

Primary Outcome Measures :
  1. Scar Assessment [ Time Frame: 1 Day ]
    Vancouver Scar Scale assessment of dermatome wounds previously treated with Santyl Ointment or White Petrolatum

Secondary Outcome Measures :
  1. Scar Quality [ Time Frame: 1 Day ]
    Quality of scars over time will be assessed with the BTC-2000 instrument assessment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01705860

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United States, Texas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
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Study Chair: Herbert B Slade, MD Healthpoint
Principal Investigator: Shai Rozen, MD University of Texas Southwestern Medical Center
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Responsible Party: Healthpoint Identifier: NCT01705860    
Other Study ID Numbers: 017-101-09-032
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013
Keywords provided by Healthpoint:
Collagen, collagenase, scar