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

NCT ID: NCT01670201

Last Updated: 2014-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-02-28

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mepilex Transfer Ag

Intervention Type: DEVICE

Silver dressing

Interventions

Mepilex Transfer Ag

Silver dressing

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole Gibran, MD

Role: PRINCIPAL_INVESTIGATOR

UW Medicine Regional Burn Center Seattle, WA 98104

Locations

LongIsland Plastic Surgical Group, PC

Garden City, New York, United States

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

MxT Ag 01

Identifier Type: -

Identifier Source: org_study_id