Mepilex Ag vs. Xeroform in Pediatric Patients That Sustain Partial Thickness Burn Injury

January 23, 2023 updated by: Elika Ridelman, Wayne State University

Comparative Prospective Study of Mepilex Ag vs. Xeroform in Pediatric Patients That Sustain Partial Thickness Burn Injury

Pediatric patients that sustain partial thickness burn injuries to their extremities require regular scheduled dressings and weekly appointments for better healing. Typically, the dressing used at Children's Hospital of Michigan is Xeroform, which can often be painful when changing at the weekly clinic appointment. Mepilex Ag is also an approved treatment for these types of burns and has the potential to cause less pain with dressing changes, however is not used as frequently due to a much higher cost. Studies evaluating the treatment of partial thickness burns in pediatric patients have shown decreased cost and length of stay associated with dressings that are silver impregnated, like Mepilex Ag. However, these studies are all retrospective with a possible selection bias to patients. In addition, several studies have suggested less pain with newer foam and hydrofiber dressings. We are conducting a prospective study using patients with partial thickness burns of their extremities, applying Xeroform on half of the burn, and Mepilex Ag on the other half of the burn, to remove confounding variables between patients to determine the optimal burn dressing for partial thickness scald burns for pediatric patients. A partial thickness burn, also known as a second degree burn, extends into the top two layers of the skin, not passing the hypodermis. Our goal is to determine if Xeroform or Mepilex Ag is superior treatment for partial thickness burns in pediatric patients for healing time, appearance of scar, and patient pain and comfort during treatment and dressing changes.

Study Overview

Detailed Description

The patients will be recruited at the Children's Hospital of Michigan burn center or clinic by research personnel. If a patient is determined to fit inclusion criteria, parental consent will be obtained using the attached consent form by one of the research personnel. If the parent speaks another language, written consent will be obtained after explanation of the study and a short consent form in the native language. Also, a translator will be used to explain the full consent form used for English speaking patients. This form will be witnessed by a person who speaks the native language fluently. Only one parent will be required to sign consent as many patients only have one parent available in the hospital with them and this study involves only treatments that are current standard of care. If the patient is ages 7-12 years, an oral assent will be completed before participation in the study. If the patient is between ages 13-17, an assent form will be explained to them and their signature required to participate in the study. If they speak another language, assent will be obtained using a translator and the same methods listed above for parental consent. If the recruitment accrues beyond 4-6 non-english speaking participants, who speak a certain language, the consent forms will be translated into this language for future participants.

Study Protocol:

Once consent is obtained, and the patient is determined to be ready for a dressing application, one half of the extremity burn will be treated with Mepilex Ag and the other half of the extremity burn will be treated with Xeroform. Both of these treatments are current standard of care for a partial thickness scald burn in pediatric patients. The patients will be followed inpatient until they are discharged and then followed weekly at burn clinic appointments, the same care all of our burn patients receive. A survey will be administered to burn staff and patient's parents when the treatments are applied, at follow-up clinic appointments, and after the wound is healed completely. We will evaluate clinician and nurse ease of use, comfort of each dressing for the child, pain and itching associated with each dressing and dressing change, healing time, appearance of the scar after it is completely healed using the Vancouver Scar Scale, and parental satisfaction and ease of use for each dressing.

Data Collection and Evaluation:

A chart review will be performed for all patients to obtain demographic data including age, name, birth date, date of injury, injury details, the initial treatment applied if a different dressing was used before the patient was ready for application of Xeroform or Mepilex Ag, and any other pertinent information regarding the burn treatment. Study personnel and an attending physician will evaluate each patient at weekly follow-up visits or inpatient if the patient is being treated in the hospital. Survey results and other data will be evaluated after 10 patients complete treatment. Photographs taken as part of every burn patient's care may be reviewed as part of the study. These are obtained by medical photography and securely stored digitally. The Vancouver Scar Scale will be used for final evaluation of the healed scar after treatment is complete.

All data obtained in paper form will be stored in a locked filing cabinet in a locked office in the Pediatric Surgery Department and data obtained in digital form will be secure in a password protected file on the electronic medical record server.

Statistics will be performed using Statistical Package for Social Sciences (IBM version 22.0) and the statistical program R (r-project.org). The statistics to be performed for continuous variables (which are most of the assessment measures) will include a dependent groups analysis (e.g. paired samples t-test or robust analogue of this test such as Yuen's method for trimmed means, comparing medians, or bootstrap methods). The statistics to be performed for dichotomous measures will be the Sign test, which assesses differences in positive and negative outcomes for each treatment group.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Christina Shanti, MD
  • Phone Number: 3137455881
  • Email: CShanti@dmc.org

Study Locations

    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients under age 17 presenting to Children's Hospital of Michigan burn center or burn clinic with partial thickness, second degree scald burns to extremities.
  • Burn of 1% TBSA or greater
  • Within 48 hours of injury.
  • Signed consent form (and oral assent for patients ages 7-12 or written assent for patients 13 years of age or greater).

Exclusion Criteria:

  • Flame burns
  • age over 18 years
  • infection
  • skin graft or donor site
  • burns greater than 48 hours old.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Xeroform Control
A single wound is treated with both the control (xeroform dressing) and intervention (Mepilex Ag). Approximately 50% of the wound is treated with xeroform dressing, which is the standard of care.
Standard of care dressing for low to medium exuding burns and wounds.
Experimental: Mepilex Ag Intervention
A single wound is treated with both the control (xeroform dressing) and intervention (Mepilex Ag). Approximately 50% of the wound is treated with Mepilex Ag; the product being tested.
Dressing for low to medium exuding burns and wounds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scar Evaluation
Time Frame: burn injury healing time; up to 10 weeks

Vancouver Scar Scale: 0 is defined as normal in all instances

  • Vascularity: 0 to 3
  • Pigmentation: 0 to 3
  • Pliability/Elasticity: 0 to 5
  • Height: 0 to 3
  • Pain: 0 to 2
  • Itchiness: 0 to 2
burn injury healing time; up to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dressing Change Survey
Time Frame: during the burn injury treatment, up to 10 weeks
  • Ease of application: 1 to 3; 3 is easiest
  • Pain during application: 1 to 10; 10 is most painful
during the burn injury treatment, up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Elika Ridelman, PhD, Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 061019MP2E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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