Impact of Prisma on Donor Site Pain

NCT04050124 | Completed Results FDA Device

• 1 other identifier: 19-00437
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Graft Disorder; Donor Site Complication

Keywords

Donor site pain after skin graft harvesting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Promogran Prisma

EXPERIMENTAL

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; Device: Standard of care (SOC) dressings

Standard of care (SOC) dressings

ACTIVE COMPARATOR

Device: Standard of care (SOC) dressings

Interventions

Promogran Prisma DEVICE

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

Promogran Prisma

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.

Promogran Prisma; Standard of care (SOC) dressings

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled to undergo STSG for any reason
• Patient, or designated healthcare proxy, has read and signed the IRB-approved informed consent form.

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Bandages

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Scott Gorenstein, MD
• Organization: NYU Langone Health

Scott.Gorenstein@nyulangone.org

5166638498

Study Officials

• Scott Gorenstein, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 8, 2019
• Study Start: November 7, 2019
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-03

Locations

US (1)