Donor Site Complication Clinical Trial
Official title:
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Adequacy of a New Donor Site Dressing in Surgical Burn Patients.
The investigator will identify the test donor site and test location will be considered on
the upper anterior thighs as being the most suitable if available. Circumferential donors
will be considered acceptable as well.
Treatment will be initiated in the operation room following debridement and split thickness
grafting of wounds. Donors will be harvested at 0.010 - 0.012 in. thickness. Treatment and
dressing of test donor site will include hemostasis post harvesting with epinephrine-soaked
lap sponges. Once adequate hemostasis is achieved, a Mepilex Transfer Ag dressing will be
applied directly to study site. Secondary dressing will include covering with ace wrap.
Healing should be asses after 10-14 days.
A prospective, open, non-controlled clinical investigation to evaluate the adequacy of donor site healing when using a new donor site dressing, Mepilex Transfer Ag approximately 20 subjects from 2 centres in the US, presenting with the need for surgical intervention and grafting for burn injury will be enrolled. Eligible subjects will have a selected donor site designated as a "study site". ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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