Skin Graft DisorderNCT04050124
Impact of Prisma on Donor Site Pain
A study testing Promogran Prisma in people with Skin Graft Disorder and Donor Site Complication, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Skin Graft Disorder, Donor Site Complication
- What is being tested?
- Promogran Prisma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2019to 29 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled to undergo STSG for any reason
- Patient, or designated healthcare proxy, has read and signed the IRB-approved informed consent form.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Promogran Prisma™ on Pain of Split-thickness Skin Graft Donor Sites Compared to Standard of Care Alone
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.
- Conditions
- Skin Graft Disorder, Donor Site Complication
- Being tested
- Promogran Prisma, Standard of care (SOC) dressings
- Keywords
- Donor site pain after skin graft harvesting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promogran PrismaDevice
Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix
Standard of care (SOC) dressingsDevice
standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Promogran Prisma; Device: Standard of care (SOC) dressings |
| Standard of care (SOC) dressings | Active comparator | Not described Receives: Device: Standard of care (SOC) dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start7 Nov 2019
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin Graft DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Gorenstein, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050124
- Sponsor's protocol ID
- 19-00437
- Status last verified
- Mar 2024
- First submitted
- 7 Aug 2019
- Last updated
- 16 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Promogran Prisma™ on Pain of Split-thickness Skin Graft Donor Sites Compared to Standard of Care Alone
- ClinicalTrials.gov ID
- NCT04050124
- Acronym / sponsor ID
- 19-00437
- Conditions
- Skin Graft Disorder, Donor Site Complication
- Keywords
- Donor site pain after skin graft harvesting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Posted 16 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promogran Prisma | Experimental | Device: Promogran Prisma, Device: Standard of care (SOC) dressingsFollowing 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 | Device: Standard of care (SOC) dressings |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient scheduled to undergo STSG for any reason
- Patient, or designated healthcare proxy, has read and signed the IRB-approved informed consent form.
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Promogran PrismaPromogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix | Device | Promogran Prisma |
| Standard of care (SOC) dressingsstandard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study. | Device | Promogran Prisma, Standard of care (SOC) dressings |
Primary outcome
Pain Score on Visual Analogue Scale (VAS)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Scott Gorenstein, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promogran Prisma in people with Skin Graft Disorder and Donor Site Complication, run by NYU Langone Health at 1 site in United States.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 16 Apr 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score on Visual Analogue Scale (VAS) (time frame: Postoperative Day 1). 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 16 Apr 2024.