Clinical trial NCT01670201: An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients
Official title: A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Adequacy of a New Donor Site Dressing in Surgical Burn Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Donor Site Complication
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2012-08-22
Enrollment: 8
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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".

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

Primary outcomes:
measure: Percentage of Participants Who Had > 95 % Epithelialization at Day 10
timeFrame: 10 days
Secondary outcomes:
measure: Pain at Dressing Changes
timeFrame: 28 days
Other outcomes:
Locations:
city: Garden City
country: United States
facility: LongIsland Plastic Surgical Group, PC
state: New York
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: UW Medicine Regional Burn Center Seattle, WA 98104
name: Nicole Gibran, MD
role: PRINCIPAL_INVESTIGATOR
References: