BurnsNCT06163742
Novel Donor Site Dressing (Product X)
A study testing Product X and Standard-of-Care in people with Burns, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Product X and Standard-of-Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- Patients who are moribund.
- Pregnancy.
- Active cancer and currently undergoing treatment.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hamilton General Hospital
Hamilton, Ontario, L8L2X2
Marc G Jeschke, MD PhD, 9055212100 ext. 40694, marc.jeschke@hhsc.ca
Marc G Jeschke, MD PhD
About this study
Official title: 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.
Read more
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
- Being tested
- Product X, Standard-of-Care
- Keywords
- Donor Site, Burns, Wound Healing
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product XDevice
The investigational device is a polyethylene glycol-based biomaterial. It can be applied to donor sites on the arms, torso, and legs.
Standard-of-CareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-Care | Active comparator | Not described Receives: Device: Standard-of-Care |
| Product X | Experimental | Not described Receives: Device: Product X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of donor site infections
Donor site infection requiring antibiotic/antifungal treatment or additional (unplanned) OR.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study startNov 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc G Jeschke, MD PhD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163742
- Sponsor's protocol ID
- 16307
- Status last verified
- Feb 2024
- First submitted
- 18 Aug 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized Trial to Determine the Safety of a Novel Donor Site Dressing (Product X)
- ClinicalTrials.gov ID
- NCT06163742
- Acronym / sponsor ID
- 16307
- Conditions
- Burns
- Keywords
- Donor Site, Burns, Wound Healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-Care | Active comparator | Device: Standard-of-Care |
| Product X | Experimental | Device: Product X |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (3 listed)
- Patients who are moribund.
- Pregnancy.
- Active cancer and currently undergoing treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Product XThe investigational device is a polyethylene glycol-based biomaterial. It can be applied to donor sites on the arms, torso, and legs. | Device | Product X |
| Standard-of-CareThe 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. | Device | Standard-of-Care |
Primary outcome
Number of donor site infections
Time frame: 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.
Number of non-healing donor sites
Time frame: 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.
Poor scarring requiring additional (unplanned) OR measured with the Patient Observer Scar Assessment Score (POSAS).
Time frame: 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.
8 secondary outcomes
The amount of excess bleeding from the donor site measured by the need for interventions to control the bleeding.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.
Donor Site Pain
Time frame: From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.
Itch
Time frame: From application of the donor site dressing until last dressing takedown, assessed up to 52 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc G Jeschke, MD PhD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product X and Standard-of-Care in people with Burns, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc G Jeschke, MD PhD (9055212100 ext. 40964, marc.jeschke@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of donor site infections (time frame: From date of donor site dressing application until date of hospital discharge, assessed up to 52 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.