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

Donor Site Complication Clinical Trial

Official title:

A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Adequacy of a New Donor Site Dressing in Surgical Burn Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670201
• Other study ID #: MxT Ag 01
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: September 3, 2014
• Start date: September 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Donor Site Complication

Intervention

Device:
• Mepilex Transfer Ag
Silver dressing

Locations

Country	Name	City	State
United States	LongIsland Plastic Surgical Group, PC	Garden City	New York
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Had > 95 % Epithelialization at Day 10		10 days	No
Secondary	Pain at Dressing Changes	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.	28 days	No