Back to resultsKerecis Fish Skin Grafts With and Without Platelet Rich Plasma (PRP)
Primary Purpose
Non-healing Wound
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet Rich Plasma
Sponsored by
About this trial
This is an interventional treatment trial for Non-healing Wound focused on measuring xenograft, PRP, platelet rich plasma
Eligibility Criteria
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.
Sites / Locations
- St. Elizabeth Healthcare Edgewood
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Xenograft only
Xenograft and PRP
Arm Description
The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied without the application of PRP.
The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied with the application of PRP.
Outcomes
Primary Outcome Measures
Time to wound being deemed healed or 6 months
Assessed by time, surface area of wound, wound volume and relative surface size
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05766982
Brief Title
Kerecis Fish Skin Grafts With and Without Platelet Rich Plasma (PRP)
Official Title
Fish Skin Grafts With Platelet-rich Plasma Compared to Fish Skin Grafts for Chronic Wound Healing: Randomized, Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St Elizabeth Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This prospective, randomized pilot study compares the use of a xenograft with PRP to a xenograft alone for chronic, nonhealing wounds.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-healing Wound
Keywords
xenograft, PRP, platelet rich plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be a 1:1 randomized controlled trial with parallel group assignment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xenograft only
Arm Type
No Intervention
Arm Description
The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied without the application of PRP.
Arm Title
Xenograft and PRP
Arm Type
Experimental
Arm Description
The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied with the application of PRP.
Intervention Type
Other
Intervention Name(s)
Platelet Rich Plasma
Intervention Description
Platelet rich plasma will be applied to assess rate of wound healing.
Primary Outcome Measure Information:
Title
Time to wound being deemed healed or 6 months
Description
Assessed by time, surface area of wound, wound volume and relative surface size
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Wound quality of life
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Paulson
Phone
859-301-5912
Email
sally.paulson@stelizabeth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Harm
Email
richard.harm@stelizabeth.com
Facility Information:
Facility Name
St. Elizabeth Healthcare Edgewood
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katy Fischesser
Phone
859-301-5887
Email
katy.fischesser@stelizabeth.com
First Name & Middle Initial & Last Name & Degree
John Eldridge
First Name & Middle Initial & Last Name & Degree
Zachary Glenn
First Name & Middle Initial & Last Name & Degree
Gregory Worley
12. IPD Sharing Statement
Learn more about this trial
Kerecis Fish Skin Grafts With and Without Platelet Rich Plasma (PRP)
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