Effect of Collagenase on Healing and Scarring

Phase 4

Completed

• Conditions: Scarring; Impaired Wound Healing
• Interventions: Drug: Collagenase Santyl; Drug: Collagenase Santyl Vehicle

• Registration Number: NCT00651820
• Lead Sponsor: Healthpoint

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-20
• Study Start: 2008-04
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-03
• Primary Completion: 2009-11
• Study Completion: 2010-03
• Results First Submitted: 2010-06-04
• Results First Submitted QC: 2011-01-07
• Results First Posted: 2011-01-26
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collagenase Santyl Rate of Wound Closure	Collagenase Santyl	Dermatome-induced skin wounds treated with drug active (collagenase).
Vehicle Rate of Wound Closure	Collagenase Santyl Vehicle	Dermatome-induced skin wounds treated with Vehicle alone.

Primary Outcome Measures

Name	Time	Method
Time to Complete Wound Closure Collagenase Santyl and Vehicle	21 days

Secondary Outcome Measures

Name	Time	Method
Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle	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.

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States