Status:
COMPLETED
Evaluation of Post Burn Rehabilitation Population for Itch Control
Lead Sponsor:
Swiss-American Products, Inc
Collaborating Sponsors:
McGill University
Hospital de readaptation Villa Medica
Conditions:
Pruritus
Itching
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Severe itching following burn injury is a common complication. As many as 87% of burn patients report severe itching. The intense itching can increase anxiety and can interfere with sleep and normal a...
Detailed Description
The mechanism of pruritus is poorly understood, but much stems from the inflammatory process during wound healing. Damaged nerve endings, substance P, mast cells releasing histamines, and presence of ...
Eligibility Criteria
Inclusion
- Post burn subject must be experiencing pruritus as defined by
- at least three episodes of itch during the past week AND
- itching occurs at least twice during the episode day AND
- itching lasts for more than 5 minutes and is bothersome
- TBSA of burn is between 10 and 70%
- Currently performing rehabilitation at Villa Medica Rehabilitation Hospital
- Subject available for 4 weeks
- Test area has complete epithelialization
- Subject is willing to complete daily diary
- Subject is male or female and over 18 years of age
Exclusion
- Subject will be excluded if pruritus is of nonburn etiology
- Subject requires topical steroids, topical antihistamines, or other topical medication and such medication cannot be discontinued
- Subject with known sensitivity to the enzyme papain or to the papaya fruit
- Subject requires immunosuppressives such as systemic steroid therapy, cancer chemotherapeutic agents
- Subject presently requires morphine for pain relief
- Subject is a known alcohol or drug abuser
- Subject is unable to communicate pain and itch scores or medication used
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00782054
Start Date
September 1 2006
End Date
April 1 2008
Last Update
October 29 2008
Active Locations (1)
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1
Villa Medica Rehabilitation Hospital
Montreal, Quebec, Canada, H2W 1T8