NCT04050124

Impact of Prisma on Donor Site Pain

Impact of Promogran Prisma™ on Pain of Split-thickness Skin Graft Donor Sites Compared to Standard of Care Alone

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-11-07
• Primary completion: 2021-11-29
• Completion: 2021-11-29
• First posted: 2019-08-08
• Last updated: 2024-04-16
• Results posted: 2024-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study