Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Mepilex Transfer Ag

Device
Who is being recruted

Over 7 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorMolnlycke Health Care AB
Last updated: September 10, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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".

NCT01670201
Principal SponsorMolnlycke Health Care AB
Last updated: September 10, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

8 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 7 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Both genders with an age >= 7 years at enrolment
Burn of thermal origin
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
Show More Criteria
9 exclusion criteria prevent from participating
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
Any known or suspected systemic infection
Any known sensitivity to silver or other components/products used in this study
Bleeding disorders
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

LongIsland Plastic Surgical Group, PC

Garden City, United StatesOpen LongIsland Plastic Surgical Group, PC in Google Maps

Harborview Medical Center

Seattle, United States
Completed2 Study Centers