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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01670201
First received: June 12, 2012
Last updated: September 3, 2014
Last verified: February 2013
  Purpose

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.


Condition Intervention
Donor Site Complication
Device: Mepilex Transfer Ag

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • Percentage of Participants Who Had > 95 % Epithelialization at Day 10 [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain at Dressing Changes [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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.



Enrollment: 8
Study Start Date: September 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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".

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670201

Locations
United States, New York
LongIsland Plastic Surgical Group, PC
Garden City, New York, United States, 11530
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
Principal Investigator: Nicole Gibran, MD UW Medicine Regional Burn Center Seattle, WA 98104
  More Information

No publications provided

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01670201     History of Changes
Other Study ID Numbers: MxT Ag 01
Study First Received: June 12, 2012
Results First Received: April 3, 2014
Last Updated: September 3, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 30, 2014