NCT01670201

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 a New Donor Site Dressing in Surgical Burn Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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".

Conditions

• Donor Site Complication

Interventions

Type	Name	Description
DEVICE	Mepilex Transfer Ag	Silver dressing

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-08-22
• Last updated: 2014-09-10
• Results posted: 2014-09-10

Locations

2 sites across 1 country: United States