Kerecis Fish Skin Grafts With and Without Platelet Rich Plasma (PRP)

NCT05766982 | Withdrawn FDA Device

• 1 other identifier: ELD.001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized pilot study compares the use of a xenograft with PRP to a xenograft alone for chronic, nonhealing wounds.

Conditions

Non-healing Wound

Keywords

xenograft; PRP; platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• Time to wound being deemed healed or 6 months

  Assessed by time, surface area of wound, wound volume and relative surface size

  6 months

Secondary Outcomes (1)

• Wound quality of life

  6 months

Study Arms (2)

Xenograft only

NO INTERVENTION

The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied without the application of PRP.

Xenograft and PRP

EXPERIMENTAL

The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied with the application of PRP.

Other: Platelet Rich Plasma

Interventions

Platelet Rich Plasma OTHER

Platelet rich plasma will be applied to assess rate of wound healing.

Xenograft and PRP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is over the age of 18 years;
• The targeted wound is deemed a chronic, nonhealing wound after six weeks of treatment; - - Patient of Dr. Eldridge, Dr. Glenn, or Dr. Worley;
• Target wound size must be between 2 cm x 2 cm x 0.1 cm deep and 10 cm x 10 cm x 5 cm deep;
• Surgical candidate for standard of care Kerecis® xenograft surgery.

You may not qualify if:

• Patient with hemoglobin values less than 6.9 g/dL drawn at least 30 days prior to the Kerecis® xenograft surgery;
• Patient with a known allergy or other sensitivity to fish material;
• Patient is currently undergoing chemotherapy or radiation therapy;
• The targeted wound is of autoimmune origin; and Non-English-speaking patients.

Sponsors & Collaborators

• St Elizabeth Healthcare: lead

Study Sites (1)

St. Elizabeth Healthcare Edgewood

Edgewood, Kentucky, 41017, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be a 1:1 randomized controlled trial with parallel group assignment.

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 13, 2023
• Study Start: January 30, 2024
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

US (1)