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

Non-healing Wound Clinical Trial

Official title:

Fish Skin Grafts With Platelet-rich Plasma Compared to Fish Skin Grafts for Chronic Wound Healing: Randomized, Prospective Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05766982
• Other study ID #: ELD.001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: September 2025

Study information

• Verified date: April 2023
• Source: St Elizabeth Healthcare
• Contact: Sally Paulson
• Phone: 859-301-5912
• Email: sally.paulson[@]stelizabeth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: September 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ichthyosis
• Non-healing Wound

Intervention

Other:
• Platelet Rich Plasma
Platelet rich plasma will be applied to assess rate of wound healing.

Locations

Country	Name	City	State
United States	St. Elizabeth Healthcare Edgewood	Edgewood	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
St Elizabeth Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound quality of life	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.	6 months