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OpenTrials
Completed

NCT Number: NCT00651820

Effect of Collagenase on Healing and Scarring

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.

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Key information

Conditions

Scarring Cicatrix Fibrosis Impaired Wound Healing Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provide written informed consent
  • Willing to attend all required study visits

Exclusion criteria

  • Known hypersensitivity to Clostridial collagenase
  • Anticoagulants (blood thinners, including aspirin) within two weeks
  • Congenital skin disorder which affects keratinocytes, elastin, or collagen
  • Any dermatologic disease which may be aggravated or provoked by the wounding procedure
  • Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding
  • At risk of keloid or hypertrophic scar formation
  • Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed
  • Any skin disorder which causes delayed healing
  • Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome
  • 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

Treatment and study plan

Collagenase Santyl

Drug

Dermatome-induced skin wounds treated with drug active.

Each subject serves as his own control receiving both treatments in parallel.

Collagenase Santyl Vehicle

Drug

Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.

Primary outcomes

  1. Time to Complete Wound Closure Collagenase Santyl and Vehicle

    Time frame: 21 days

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Healthpoint

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 3, 2008
Registry last updated
Jun 9, 2011

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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