Impact of Prisma on Donor Site Pain (NCT04050124) | Clinical Trial Compass
CompletedNot Applicable
Impact of Prisma on Donor Site Pain
United States17 participantsStarted 2019-11-07
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at pain at skin graft donor sites using a pain scale — can you tell me what the Prisma dressing actually is and how it's thought to reduce donor site pain compared to what's currently used on my wound?
2Since this trial has already been completed, have the results been published, and do they show any meaningful difference in pain scores that might change how you'd manage my donor site?
3The trial focused specifically on donor site complications — are there any wound care approaches you'd recommend for me right now based on evidence like this, or are we still waiting on stronger data?
4How does donor site pain typically progress over time, and is managing that pain with something like Prisma something worth discussing as part of my overall skin graft care plan?
5Are there any risks or downsides to using newer wound dressings like the one studied in this trial that I should weigh against the potential benefit of less pain at the donor site?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.