Impact of Prisma on Donor Site Pain

NYU Langone Health

Status: Completed

Conditions: Donor Site Complication; Skin Graft Disorder

Treatments: Device: Promogran Prisma; Device: Standard of care (SOC) dressings

Study type: Interventional

Funder types: Other

Identifiers

NCT04050124

19-00437

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Promogran Prisma

Experimental group

Description:

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.

Treatment:

Device: Standard of care (SOC) dressings

Device: Promogran Prisma

Standard of care (SOC) dressings

Active Comparator group

Treatment:

Device: Standard of care (SOC) dressings