Impact of Prisma on Donor Site Pain

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.

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Key information

Conditions

Skin Graft Disorder Donor Site Complication

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Promogran Prisma

Device

Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix

Standard of care (SOC) dressings

Device

standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Impact of Promogran Prisma™ on Pain of Split-thickness Skin Graft Donor Sites Compared to Standard of Care Alone

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Aug 8, 2019
Registry last updated: Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed