Novel Donor Site Dressing (Product X)

Hamilton Health Sciences (HHS)

Status: Not yet enrolling

Conditions: Burns

Treatments: Device: Product X; Device: Standard-of-Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06163742

16307

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥18 years of age;
2. <25% total body surface area (TBSA) burn;
3. Deep partial or full-thickness burn requiring operative procedures;
4. Autologous donor site(s) on thigh, torso, and/or arm.

Exclusion criteria

1. Patients who are moribund.
2. Pregnancy.
3. Active cancer and currently undergoing treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Standard-of-Care

Active Comparator group

Treatment:

Device: Standard-of-Care

Product X

Experimental group

Treatment:

Device: Product X