Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163742
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-08-18
Brief Title:
Novel Donor Site Dressing Product X
Sponsor:
Hamilton Health Sciences Corporation
Organization:
Hamilton Health Sciences Corporation
Study Overview
Official Title:
A Phase III Randomized Trial to Determine the Safety of a Novel Donor Site Dressing Product X
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None