N/A N=17 Randomized Treatment

Impact of Prisma on Donor Site Pain

Skin Graft Disorder · Donor Site Complication

Bottom Line

View on ClinicalTrials.gov: NCT04050124 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2024

Primary outcome: Primary: Pain Score on Visual Analogue Scale (VAS) — 2; 2 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Promogran Prisma (Device); Standard of care (SOC) dressings (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Score on Visual Analogue Scale (VAS)	2; 2	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04050124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.