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

• ClinicalTrials.gov Identifier: NCT01670201
• Recruitment Status: Completed
• First Posted: August 22, 2012
• Results First Posted: September 10, 2014
• Last Update Posted: September 10, 2014
• Sponsor: Molnlycke Health Care AB
• Information provided by (Responsible Party): Molnlycke Health Care AB

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Donor Site Complication	Device: Mepilex Transfer Ag	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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.
• Study Start Date: September 2012
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: February 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Who Had > 95 % Epithelialization at Day 10 [ Time Frame: 10 days ]

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 7 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Molnlycke Health Care AB
• ClinicalTrials.gov Identifier: NCT01670201
• Other Study ID Numbers: MxT Ag 01
• First Posted: August 22, 2012
• Results First Posted: September 10, 2014
• Last Update Posted: September 10, 2014
• Last Verified: February 2013