New Dressing for Burns
Trial Summary
What is the purpose of this trial?
The goal of this clinical trial is to test a novel donor site dressing called Product X in burn patients requiring skin grafting procedures. A donor site is an area where the surgeon has taken a layer of skin to create a graft. This is required to make severe burn wounds heal. However, donor sites often experience infection, pain, and itch that can delay the healing of the donor site. To prevent these complications, donor sites are covered with dressings to prevent infection and absorb fluids from the wounds. Many options exist, but no single dressing is best, especially for pain management and the ability to absorb fluids from wounds effectively. The investigators have developed a new donor site dressing to meet the criteria of an "ideal dressing," called Product X. The main question this clinical trial aims to determine the safety and potential wound-healing benefits of this donor site dressing as a new therapy that will help patients who require donor sites. Participants will: * Be randomized, like a flip of a coin, to receive either Product X or the standard-of-care dressings. If patients have one donor site, it will be randomized to receive either Product X or the standard-of-care dressings, Allevyn and Xeroform. If they have two donor sites, one donor site will be randomized to receive Product X and the other to receive standard-of-care dressings. * Have photographs of their donor sites taken at the operation, during dressing changes, at discharge, and at regularly scheduled outpatient follow-up appointments with the burn clinic. * Complete short questionnaires to assess their comfort (pain and itch) with their donor sites daily. * Complete a scar formation questionnaire at your regularly scheduled follow-up appointments in the outpatient burn clinic. Researchers will compare Product X to standard-of-care dressings (Allevyn and Xeroform) to see if there are improvements in wound healing, pain, itch, and infection.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How does the new dressing for burns differ from other treatments?
The new dressing, Aquacel Ag, is unique because it is a silver-containing hydrofiber that releases silver for up to two weeks, promoting a healing environment and requiring fewer dressing changes compared to other treatments. This reduces pain and is easy to apply, making it particularly beneficial for managing partial-thickness burns in children.12345
Research Team
Marc G Jeschke, MD PhD
Principal Investigator
Hamilton Health Sciences Corporation
Eligibility Criteria
This trial is for adults over 18 with deep burns covering less than a quarter of their body, needing skin grafts from their thigh, torso, or arm. It's not for those at the end of life, pregnant women, or active cancer patients under treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either Product X or standard-of-care dressings, with photographs and questionnaires completed during dressing changes and at discharge.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including scar formation and healing assessments at 3 and 6 months post-discharge.
Treatment Details
Interventions
- Product X
- Standard-of-Care
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hamilton Health Sciences Corporation
Lead Sponsor