Novel Donor Site Dressing (Product X)

Not Applicable

Not yet recruiting

• Conditions: Burns
• Interventions: Device: Product X; Device: Standard-of-Care

• Registration Number: NCT06163742
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Study Start: 2024-11
• Primary Completion: 2025-10
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Product X	Product X	-
Standard-of-Care	Standard-of-Care	-

Primary Outcome Measures

Name	Time	Method
Poor scarring requiring additional (unplanned) OR measured with the Patient Observer Scar Assessment Score (POSAS).	At 3 months and 6 months post-hospital discharge.	Scores will range from 1 to 10 for each measure, with higher scores indicating worse scarring.
Number of non-healing donor sites	From date of donor site dressing application until date of hospital discharge, assessed up to 52 weeks.	Non-healing donor site requiring additional (unplanned) OR.
Number of donor site infections	From date of donor site dressing application until date of hospital discharge, assessed up to 52 weeks.	Donor site infection requiring antibiotic/antifungal treatment or additional (unplanned) OR.

Secondary Outcome Measures

Name	Time	Method
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.
Range of motion of the donor site measured by the ability to actively participate in therapy sessions.	From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.	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.
Itch	From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.	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).
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.	Photography and evaluation of the donor site at operation, dressing-take downs, and discharge from the hospital.
Scar formation over time using the Patient and Observer Scar Assessment Scale	At 3 months and 6 months post-hospital discharge.	Scores will range from 1 to 10 for each measure, with higher scores indicating worse scarring.
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.	Greater amounts of dressings required and greater numbers of dressing changes indicate worse absorbability.
Donor Site Pain	From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.	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).
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.	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.

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada