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

NCT01670201 | Completed Results

• 1 other identifier: MxT Ag 01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Donor Site Complication

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Had > 95 % Epithelialization at Day 10

  10 days

Secondary Outcomes (1)

• Pain at Dressing Changes

  28 days

Study Arms (1)

Mepilex Transfer Ag

EXPERIMENTAL

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

Interventions

Mepilex Transfer Ag DEVICE

Silver dressing

Mepilex Transfer Ag

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (2)

LongIsland Plastic Surgical Group, PC

Garden City, New York, 11530, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Results Point of Contact

• Title: Dr Nicole Gibran
• Organization: Harborview Medical Center / Seattle, Washington

nicoleg@uw.edu

206-744-3140

Study Officials

• Nicole Gibran, MD

  UW Medicine Regional Burn Center Seattle, WA 98104

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: August 22, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 10, 2014
• Results First Posted: September 10, 2014

Record last verified: 2013-02

Locations

US (2)