Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the feasibility of evaluating the use of a composite collagen, silver-oxidized regenerated cellulose matrix compared to the standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promogran Prisma | Experimental | Following standard of care split thickness skin grafting, patients randomized to the intervention group will receive Promogan Prisma as the primary contact dressing at the donor grafting site. |
|
| Standard of care (SOC) dressings | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promogran Prisma | Device | Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score on Visual Analogue Scale (VAS) | Pain score is measured using a VAS ranging from 0-10, where 0 = no pain and 10 = unbearable pain. Participants select the number that best reflects their current status. The total score is the numerical response; lower scores indicate lower pain. | Postoperative Day 1 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scott Gorenstein, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Promogran Prisma | Following standard of care split thickness skin grafting, patients randomized to the intervention group will receive Promogan Prisma as the primary contact dressing at the donor grafting site. Promogran Prisma: Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix |
| FG001 | Standard of Care (SOC) Dressings | Standard of care (SOC) dressings: standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Promogran Prisma | Following standard of care split thickness skin grafting, patients randomized to the intervention group will receive Promogan Prisma as the primary contact dressing at the donor grafting site. Promogran Prisma: Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score on Visual Analogue Scale (VAS) | Pain score is measured using a VAS ranging from 0-10, where 0 = no pain and 10 = unbearable pain. Participants select the number that best reflects their current status. The total score is the numerical response; lower scores indicate lower pain. | Posted | Median | Full Range | score on a scale | Postoperative Day 1 |
|
6 weeks
non- systematic: self report and clinical assesment on weekly clinic visits
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Promogran Prisma | Following standard of care split thickness skin grafting, patients randomized to the intervention group will receive Promogan Prisma as the primary contact dressing at the donor grafting site. Promogran Prisma: Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Gorenstein, MD | NYU Langone Health | 5166638498 | Scott.Gorenstein@nyulangone.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2020 | Mar 19, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of care (SOC) dressings | Device | standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study. |
|
| Standard of Care (SOC) Dressings |
Standard of care (SOC) dressings: standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Standard of care (SOC) dressings: standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.
|
|
| 1 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Standard of Care (SOC) Dressings | Standard of care (SOC) dressings: standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study. | 0 | 9 | 0 | 9 | 0 | 9 |
Not provided
Not provided
Not provided