Impact of Prisma on Donor Site Pain

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: Completed
• Conditions: Donor Site Complication; Skin Graft Disorder
• Intervention / Treatment: Device: Promogran Prisma; Device: Standard of care (SOC) dressings

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	Device: Promogran Prisma; Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix; Device: Standard of care (SOC) dressings; 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	Device: Standard of care (SOC) dressings; standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative Day 1

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Scott Gorenstein, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2019
• Primary Completion (Actual): November 29, 2021
• Study Completion (Actual): November 29, 2021

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): April 16, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Donor site pain after skin graft harvesting
• 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: Yes