Impact of Prisma on Donor Site Pain

February 9, 2023 updated by: NYU Langone Health

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Score between treatment and control arms
Time Frame: Day 1
The primary endpoint of this feasibility study is to evaluate if using Promogran in addition to SOC is associated with a clinically meaningful difference in pain score (≥2 points on the pain scale) between the treatment and control arms on postoperative day (POD) 1.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 7, 2019

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

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)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

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

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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