Donor Site Complication, Skin Graft Disorder
Conditions
Keywords
Donor site pain after skin graft harvesting
Brief summary
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.
Interventions
DEVICEPromogran Prisma
Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix
DEVICEStandard 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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient scheduled to undergo STSG for any reason * Patient, or designated healthcare proxy, has read and signed the IRB-approved informed consent form.
Exclusion criteria
* Active infection or history of radiation to the donor site * Patient has a known sensitivity to Promogran Prisma™ or silver * Elevated INR \>3.0 * Insensate at the donor site * Chronic narcotic use (\>6 months of daily use)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score on Visual Analogue Scale (VAS) | Postoperative Day 1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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. | 9 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
Baseline characteristics
| Characteristic | Promogran Prisma | Total | Standard of Care (SOC) Dressings |
|---|---|---|---|
| Age, Continuous | 70.5 years | 69.88 years | 69.55 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 16 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 9 Participants | 3 Participants |
| Region of Enrollment United States | 7 participants | 16 participants | 9 participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 8 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
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.
Time frame: Postoperative Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Promogran Prisma | Pain Score on Visual Analogue Scale (VAS) | 2 score on a scale |
| Standard of Care (SOC) Dressings | Pain Score on Visual Analogue Scale (VAS) | 2 score on a scale |