Effect of Collagenase on Healing and Scarring

June 7, 2011 updated by: Healthpoint

A Randomized, Double-blind, Paired-Comparison of the Effect of Collagenase Santyl® Ointment on Healing and Scarring Characteristics of 600μm Dermatome Wounds

A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment versus vehicle alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provide written informed consent
  2. Willing to attend all required study visits

Exclusion Criteria:

  1. Known hypersensitivity to Clostridial collagenase
  2. Anticoagulants (blood thinners, including aspirin) within two weeks
  3. Congenital skin disorder which affects keratinocytes, elastin, or collagen
  4. Any dermatologic disease which may be aggravated or provoked by the wounding procedure
  5. Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding
  6. At risk of keloid or hypertrophic scar formation
  7. Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed
  8. Any skin disorder which causes delayed healing
  9. Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome
  10. Taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Collagenase Santyl Rate of Wound Closure
Dermatome-induced skin wounds treated with drug active (collagenase).
Drug: Collagenase Santyl

Dermatome-induced skin wounds treated with drug active.

Each subject serves as his own control receiving both treatments in parallel.
Placebo Comparator: Vehicle Rate of Wound Closure
Dermatome-induced skin wounds treated with Vehicle alone.
Drug: Collagenase Santyl Vehicle
Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Complete Wound Closure Collagenase Santyl and Vehicle
Time Frame: 21 days
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle
Time Frame: 9 Months
Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements.
9 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthpoint

Investigators

  • Study Director: Herbert B Slade, MD, Healthpoint

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Estimate)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 017 101 09 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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