Clinical trial NCT04149808: Mepilex Ag vs. Xeroform in Pediatric Patients That Sustain Partial Thickness Burn Injury
Official title: Comparative Prospective Study of Mepilex Ag vs. Xeroform in Pediatric Patients That Sustain Partial Thickness Burn Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Second-degree Burn
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients under age 18 presenting to Children's Hospital of Michigan burn center or burn clinic with partial thickness, second degree scald burns.The burn must be at least 1% total body surface area (TBSA) or greater. The burn is divided approximately in half, with 50% of the wound receiving xeroform dressing and the remaining 50% receiving Mepilex Ag. Patients must present within 48 hours of injury. Patients must have a signed consent form (and oral assent for patients ages 7-12 or written assent for patients 13 years of age or greater).
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Scar Evaluation
timeFrame: burn injury healing time; up to 10 weeks
Secondary outcomes:
measure: Dressing Change Survey
timeFrame: during the burn injury treatment, up to 10 weeks
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
Study officials:
affiliation: Wayne State University
name: Elika Ridelman, PhD
role: STUDY_DIRECTOR
References:
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