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

NCT ID: NCT01705860

Last Updated: 2013-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Follow up to Acute Wound Scar Study

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Assessment

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Santyl

Intervention Type BIOLOGICAL

Interventions

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Santyl

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Healthpoint

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herbert B Slade, MD

Role: STUDY_CHAIR

Healthpoint

Shai Rozen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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017-101-09-032

Identifier Type: -

Identifier Source: org_study_id

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