Completed

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

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What is being collected

Biological Data

Collected from today forward - Prospective
Biological
Who is being recruted

Fibrosis+1

+ Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

From 18 to 50 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Observational
Study Start: September 2012
See protocol details

Summary

Principal SponsorHealthpoint
Last updated: April 15, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01705860
Principal SponsorHealthpoint
Last updated: April 15, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsCicatrix

Criteria

3 inclusion criteria required to participate
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
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
1 exclusion criteria prevent from participating
N/A

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Dallas, United StatesOpen in Google Maps
CompletedOne Study Center