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Impact of Prisma on Donor Site Pain

NCT04050124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-04-16

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Scott Gorenstein, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2021-11-29
Completion
2021-11-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04050124 on ClinicalTrials.gov