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

Completed · Not applicable

Conditions studied: Donor Site Complication

In brief

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.

Key facts

Study ID

NCT01670201

Run by

Molnlycke Health Care AB

People needed

8

Starts

2012-09-01

Expected to finish

2013-02-01

Last updated by the study team

2014-09-10

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Surgical donor sites for deep partial-thickness or full-thickness burns
• Burn of thermal origin
• Both genders with an age ≥ 7 years at enrolment
• Signed informed consent
• 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.

You may not qualify if…

• Any known or suspected systemic infection
• Any known sensitivity to silver or other components/products used in this study.
• 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.
• 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.
• Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
• Requires immersion hydrotherapy at any time during study participation (note, showering hydrotherapy is allowed).
• Subject unwilling to comply with 28 day follow-up.
• Participation in another investigational study while participating in this study.
• Bleeding disorders

Where it is running

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

Full record on ClinicalTrials.gov

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