An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01670201
Recruitment Status : Completed
First Posted : August 22, 2012
Results First Posted : September 10, 2014
Last Update Posted : September 10, 2014
Information provided by (Responsible Party):
Molnlycke Health Care AB

June 12, 2012
August 22, 2012
April 3, 2014
September 10, 2014
September 10, 2014
September 2012
February 2013   (Final data collection date for primary outcome measure)
Percentage of Participants Who Had > 95 % Epithelialization at Day 10 [ Time Frame: 10 days ]
Efficacy of Mepilex Transfer Ag as an adequate option for donor site healing. [ Time Frame: Post-op day 10 ]
Acceptable % of donor site healing at post-op day 10 (>95% epithelialization, verified by quantitative photographic analysis).
Complete list of historical versions of study NCT01670201 on Archive Site
Pain at Dressing Changes [ Time Frame: 28 days ]

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.

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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.

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".
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Donor Site Complication
Device: Mepilex Transfer Ag
Silver dressing
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.
Intervention: Device: Mepilex Transfer Ag
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
MxT Ag 01
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Molnlycke Health Care AB
Molnlycke Health Care AB
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Principal Investigator: Nicole Gibran, MD UW Medicine Regional Burn Center Seattle, WA 98104
Molnlycke Health Care AB
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP