Novel Donor Site Dressing (Product X)

NCT06163742 | Not Yet Recruiting

• 1 other identifier: 16307
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Donor Site; Burns; Wound Healing

Outcome Measures

Primary Outcomes (3)

• Number of donor site infections

  Donor site infection requiring antibiotic/antifungal treatment or additional (unplanned) OR.

  From date of donor site dressing application until date of hospital discharge, assessed up to 52 weeks.

• Number of non-healing donor sites

  Non-healing donor site requiring additional (unplanned) OR.

  From date of donor site dressing application until date of hospital discharge, assessed up to 52 weeks.

• Poor scarring requiring additional (unplanned) OR measured with the Patient Observer Scar Assessment Score (POSAS).

  Scores will range from 1 to 10 for each measure, with higher scores indicating worse scarring.

  At 3 months and 6 months post-hospital discharge.

Secondary Outcomes (8)

• The amount of excess bleeding from the donor site measured by the need for interventions to control the bleeding.

  From date of donor site dressing application until last dressing takedown, assessed up to 52 weeks.

• Time from autografting procedure to 95% healing of donor site.

  From date of donor site dressing application until hospital discharge, assessed up to 52 weeks.

• Scar formation over time using the Patient and Observer Scar Assessment Scale

  At 3 months and 6 months post-hospital discharge.

• Absorption of wound exudate measured daily by the amount of dressing required and the number of additional dressing changes needed.

  From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.

• Number of patients experiencing adhesion of the dressing to the donor site

  From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.

Study Arms (2)

Standard-of-Care

ACTIVE COMPARATOR

Device: Standard-of-Care

Product X

EXPERIMENTAL

Device: Product X

Interventions

Product X DEVICE

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

Product X

Standard-of-Care 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.

Standard-of-Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who are moribund.
• Pregnancy.
• Active cancer and currently undergoing treatment.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Marc G Jeschke, MD PhD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc G Jeschke, MD PhD

CONTACT

9055212100; marc.jeschke@hhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: December 11, 2023
• Study Start: November 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: April 1, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-02

Locations

CA (1)