Impact of Prisma on Donor Site Pain

Not Applicable

Completed

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

• Registration Number: NCT04050124
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-08
• Study Start: 2019-11-07
• Primary Completion: 2021-11-29
• Study Completion: 2021-11-29
• Status Verified: 2024-03
• Results First Submitted: 2024-03-20
• Results First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Results First Posted: 2024-04-16
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Promogran Prisma	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 Prisma	Standard of care (SOC) dressings	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.
Standard of care (SOC) dressings	Standard of care (SOC) dressings	-

Primary Outcome Measures

Name	Time	Method
Pain Score on Visual Analogue Scale (VAS)	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States