Study Results
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View full resultsBasic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2019-11-07
2021-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
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.
Interventions
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Promogran Prisma
Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix
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.
Eligibility Criteria
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Inclusion Criteria
* Patient, or designated healthcare proxy, has read and signed the IRB-approved informed consent form.
Exclusion Criteria
* 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)
18 Years
100 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Scott Gorenstein, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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19-00437
Identifier Type: -
Identifier Source: org_study_id
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