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

Not Applicable

Withdrawn

• Conditions: Non-healing Wound
• Interventions: Other: Platelet Rich Plasma

• Registration Number: NCT05766982
• Lead Sponsor: St Elizabeth Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-13
• Study Start: 2024-01-30
• Primary Completion: 2024-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xenograft and PRP	Platelet Rich Plasma	The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied with the application of PRP.

Primary Outcome Measures

Name	Time	Method
Time to wound being deemed healed or 6 months	6 months	Assessed by time, surface area of wound, wound volume and relative surface size

Secondary Outcome Measures

Name	Time	Method
Wound quality of life	6 months	The Wound-QoL-14 questionnaire on quality of life with chronic wounds will be used to assess changes in score prior to initial application of xenograft or xenograft/PRP to time of wound healing or 6 months, whichever comes first.

Trial Locations

Locations (1)

St. Elizabeth Healthcare Edgewood; 🇺🇸 Edgewood, Kentucky, United States