Effect of Collagenase on Healing and Scarring

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Scarring Impaired Wound Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Collagenase Santyl Rate of Wound Closure

Dermatome-induced skin wounds treated with drug active (collagenase).

Group Type EXPERIMENTAL

Collagenase Santyl

Intervention Type DRUG

Dermatome-induced skin wounds treated with drug active.

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

Vehicle Rate of Wound Closure

Dermatome-induced skin wounds treated with Vehicle alone.

Group Type PLACEBO_COMPARATOR

Collagenase Santyl Vehicle

Intervention Type DRUG

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

Interventions

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Collagenase Santyl

Dermatome-induced skin wounds treated with drug active.

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

Intervention Type DRUG

Collagenase Santyl Vehicle

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes