NCT04149808

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

Withdrawn NA Last updated 26 January 2023

What this trial tests

NA trial testing Mepilex Ag (burn dressing) in Second-degree Burn. Withdrawn.

Timeline

1 November 2019

Primary endpoint
1 September 2021

1 September 2022

Quick facts

Lead sponsor	Wayne State University
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Start date	1 November 2019
Primary completion	1 September 2021
Estimated completion	1 September 2022
Sites	1 location across United States

Drugs / interventions tested

• Mepilex Ag (burn dressing)
• Xeroform Dressing

Conditions studied

• Second-degree Burn — all drugs for Second-degree Burn →

Sponsor

Wayne State University

Who can join

Adults 7 to 17, any sex, with Second-degree Burn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.