Impact of Prisma on Donor Site Pain

Donor Site Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050124
• Other study ID #: 19-00437
• Status: Completed
• Phase: N/A
• Start date: November 7, 2019
• Est. completion date: November 29, 2021

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Donor Site Complication
• Skin Graft Disorder

Intervention

Device:
• Promogran Prisma
Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score on Visual Analogue Scale (VAS)	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.	Postoperative Day 1