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Completed

NCT Number: NCT01705860

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

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.

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Key information

Conditions

Follow up to Acute Wound Scar Study Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Santyl

Biological

Primary outcomes

  1. Scar Assessment

    Time frame: 1 Day

    Vancouver Scar Scale assessment of dermatome wounds previously treated with Santyl Ointment or White Petrolatum

Secondary outcomes

  1. Scar Quality

    Time frame: 1 Day

    Quality of scars over time will be assessed with the BTC-2000 instrument assessment

Sponsors and collaborators

Lead sponsor

Healthpoint

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 12, 2012
Registry last updated
Apr 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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