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.

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 Overview

• Status: Completed
• Conditions: Donor Site Complication
• Intervention / Treatment: Device: Mepilex Transfer Ag

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".

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Garden City, New York, United States, 11530
      • LongIsland Plastic Surgical Group, PC
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Surgical donor sites for deep partial-thickness or full-thickness burns
2. Burn of thermal origin
3. Both genders with an age ≥ 7 years at enrolment
4. Signed informed consent
5. Subjects who are younger than the legal consenting age must in addition to their own assent form have a signature from a legally authorized representative.

Exclusion Criteria:

1. Any known or suspected systemic infection
2. Any known sensitivity to silver or other components/products used in this study.
3. Any active, uncontrolled, progressive or untreated malignancy. A subject who has had a malignant disease in the past, was treated with the expectation of a cure and is currently disease-free, may be considered for study entry.
4. Use of penicillamine, corticosteroid or immunosuppressive medication within 2 months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation.
5. Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
6. Requires immersion hydrotherapy at any time during study participation (note, showering hydrotherapy is allowed).
7. Subject unwilling to comply with 28 day follow-up.
8. Participation in another investigational study while participating in this study.
9. Bleeding disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Silver dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants Who Had > 95 % Epithelialization at Day 10	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at Dressing Changes	The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days. Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS), Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst.	28 days

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Nicole Gibran, MD, UW Medicine Regional Burn Center Seattle, WA 98104

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (Estimate): August 22, 2012

Study Record Updates

• Last Update Posted (Estimate): September 10, 2014
• Last Update Submitted That Met QC Criteria: September 3, 2014
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: MxT Ag 01