- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04050124
Impact of Prisma on Donor Site Pain
February 9, 2023 updated by: NYU Langone Health
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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+SOC; composite collagen, silver-oxidized regenerated cellulose matrix
standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.
|
ACTIVE_COMPARATOR: Standard of care (SOC) dressings
|
Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain Score between treatment and control arms
Time Frame: Day 1
|
The primary endpoint of this feasibility study is to evaluate if using Promogran in addition to SOC is associated with a clinically meaningful difference in pain score (≥2 points on the pain scale) between the treatment and control arms on postoperative day (POD) 1.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 7, 2019
Primary Completion (ANTICIPATED)
August 1, 2023
Study Completion (ANTICIPATED)
August 1, 2023
Study Registration Dates
First Submitted
August 7, 2019
First Submitted That Met QC Criteria
August 7, 2019
First Posted (ACTUAL)
August 8, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 13, 2023
Last Update Submitted That Met QC Criteria
February 9, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 19-00437
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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