An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients
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".
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Adequacy of a New Donor Site Dressing in Surgical Burn Patients.|
- Efficacy of Mepilex Transfer Ag as an adequate option for donor site healing. [ Time Frame: Post-op day 10 ] [ Designated as safety issue: No ]Acceptable % of donor site healing at post-op day 10 (>95% epithelialization, verified by quantitative photographic analysis).
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Mepilex Transfer Ag
Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Device: Mepilex Transfer Ag
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670201
|Contact: Joan Wilson, RN||706 594 email@example.com|
|United States, New York|
|LongIsland Plastic Surgical Group, PC||Recruiting|
|Garden City, New York, United States, 11530|
|Contact: Shawna Moscowitz, RN 516-535-6707|
|Principal Investigator: Louiis Riina, MD|
|United States, Washington|
|Harborview Medical Center||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Shari Honari, RN 206-744-3587 firstname.lastname@example.org|
|Principal Investigator: Nicole Gibran, MD|