Novel Donor Site Dressing (Product X)

A Phase I/II Randomized Trial to Determine the Safety of a Novel Donor Site Dressing (Product X)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Burns
• Intervention / Treatment: Device: Standard-of-Care; Device: Product X

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc G Jeschke, MD PhD; Phone Number: 40964 9055212100; Email: marc.jeschke@hhsc.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L2X2
      • Hamilton General Hospital
      • Contact: Marc G Jeschke, MD PhD; Phone Number: 40694 9055212100; Email: marc.jeschke@hhsc.ca
      • Contact: Marc G Jeschke, MD PhD
      • Contact: Shahriar Shahrokhi, MD
      • Contact: Margarita Elloso, MD MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard-of-Care	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.
Experimental: Product X	Device: Product X; The investigational device is a polyethylene glycol-based biomaterial. It can be applied to donor sites on the arms, torso, and legs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Photography and evaluation of the donor site at operation, dressing-take downs, and discharge from the hospital.	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	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.
Absorption of wound exudate measured daily by the amount of dressing required and the number of additional dressing changes needed.	Greater amounts of dressings required and greater numbers of dressing changes indicate worse absorbability.	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	Adhesion of the dressing to the donor site will be measured as: no adhesion, partial adhesion, or adhesion of the dressing to the donor site, with adhesion of the dressing to the donor site area having worse outcomes.	From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.
Range of motion of the donor site measured by the ability to actively participate in therapy sessions.	Assessed in terms of the patient's subjective limitations in moving the donor site area. Measured as either: no limitations, minimal limitations, moderate limitations, or severe limitations in movement, with severe limitations being the worst outcome, indicating very limited movement of the donor site area.	From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.
Donor Site Pain	Subjective donor site pain will be evaluated within 24 hours of each dressing change by participants using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0 (no pain) to 10 (severe pain).	From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.
Itch	Subjective measures of the presence and severity of itch will be measured daily by patients using the ItchyQuant scale, a validated numeric itch scale. The scale ranges from 0 (no itch) to 10 (severe itch).	From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Marc G Jeschke, MD PhD, Hamilton Health Sciences Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Wound Healing; Burns; Donor Site
• Other Study ID Numbers: 16307

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No