Impact of Prisma on Donor Site Pain

NYU Langone Health17 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Graft Disorder Donor Site Complication

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Postoperative Day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.