Novel Donor Site Dressing (Product X)

NCT ID: NCT06163742

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2026-04-30

Brief Summary

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard-of-Care

Group Type: ACTIVE_COMPARATOR

Standard-of-Care

Intervention Type: DEVICE

The active comparator includes the current standard-of-care treatment: hydrocellular polyurethane dressing covered with TegadermTM film for 48 hours, followed by an occlusive gauze impregnated with 3% Bismuth Tribromorphenate in petrolatum.

Product X

Group Type: EXPERIMENTAL

Product X

Intervention Type: DEVICE

The investigational device is a polyethylene glycol-based biomaterial. It can be applied to donor sites on the arms, torso, and legs.

Interventions

Product X

The investigational device is a polyethylene glycol-based biomaterial. It can be applied to donor sites on the arms, torso, and legs.

Intervention Type: DEVICE

Standard-of-Care

The active comparator includes the current standard-of-care treatment: hydrocellular polyurethane dressing covered with TegadermTM film for 48 hours, followed by an occlusive gauze impregnated with 3% Bismuth Tribromorphenate in petrolatum.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc G Jeschke, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

Marc G Jeschke, MD PhD

Role: CONTACT

marc.jeschke@hhsc.ca

9055212100 ext. 40964

Facility Contacts

Marc G Jeschke, MD PhD

Role: primary

marc.jeschke@hhsc.ca

9055212100 ext. 40694

Marc G Jeschke, MD PhD

Role: backup

Shahriar Shahrokhi, MD

Role: backup

Margarita Elloso, MD MSc

Role: backup

Other Identifiers

16307

Identifier Type: -

Identifier Source: org_study_id