Status:
UNKNOWN
Trial of exSALT SD7™ Compared to Xeroform® Petrolatum Dressing for the Management of Partial Thickness Donor Sites
Lead Sponsor:
Exciton Technologies Inc.
Collaborating Sponsors:
Alberta Heritage Foundation for Medical Research
Epidemiology Coordinating and Research Centre, Canada
Conditions:
Wound Healing
Wound Infection
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This randomized, controlled trial is designed to evaluate split-thickness donor sites treated with exSALT SD7™ compared to donor sites treated with Xeroform®. For the purpose of this study, subjects e...
Detailed Description
Autologous skin grafting is a common procedure required in the care of burn and plastic surgery patients where the harvesting of autologous skin grafts results in the creation of a partial thickness w...
Eligibility Criteria
Inclusion
- signed or verbal informed consent provided
- are 18 to 65 years of age
- scheduled to undergo a split-thickness skin graft (autograft) that will result in a donor site or sites that are; a first time harvest and includes primarily the anterior including medial and lateral aspects of the anterior portion(s) of the thigh(s) with either; a single donor site that is a minimum of 8 x 20 cm or two donor sites are both a minimum of 8 x 8 cm and the resulting test sites are generally comparable in size and wound characteristics.
- requires hospitalization for initial treatment
Exclusion
- require full thickness graft
- known skin sensitivity to any of the dressing components
- poor prognosis and who are unlikely to survive the trial period
- participating in another concurrent trial
- exhibiting any other medical condition, which, according to the investigator, justifies the subject's exclusion from the trial
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00968994
Start Date
December 1 2009
End Date
January 1 2011
Last Update
December 24 2009
Active Locations (1)
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1
The University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7