Kerecis Fish Skin Grafts With and Without Platelet Rich Plasma (PRP)
Not Applicable
Withdrawn
- Conditions
- Non-healing Wound
- 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
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- WITHDRAWN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
- 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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the enhanced wound healing effects of fish skin xenografts combined with platelet-rich plasma in chronic non-healing wounds?
How does the efficacy of Kerecis fish skin grafts with PRP compare to standard-of-care treatments like autografts or collagen-based dressings for chronic wound management?
Which biomarkers are associated with improved outcomes in patients receiving xenograft-based therapies for non-healing wounds, particularly in diabetic or venous ulcer subtypes?
What are the potential adverse events linked to xenograft application with PRP, and how do they differ from traditional wound healing interventions in clinical practice?
Are there alternative combination therapies involving fish skin xenografts and other growth factors or bioactive compounds that show promise in chronic wound healing research?
Trial Locations
- Locations (1)
St. Elizabeth Healthcare Edgewood
🇺🇸Edgewood, Kentucky, United States
St. Elizabeth Healthcare Edgewood🇺🇸Edgewood, Kentucky, United States