Evaluation of the Safety and the Clinical Effectiveness of Using Tropocells® Autologous PRF System to Treat Chronic, Non-healing, Non-infected Wounds in Combination With Standard of Care (SOC).
Estar Medical dba Medical Technologies, LTD
Summary
Platelet-based therapies have been used to treat bony and soft tissue effects for more than 30 years. Tropocells® Autologous Platelet-Rich Fibrin (PRF) is being used to treat chronic, non-healing wounds, of a variety of types. This will help determine the safety and effective use of PRF in the treatment of soft tissue defects.
Description
Chronic wounds are wounds that fail to progress through a normal healing process in a timely fashion. Typically the wounds remain in a pro-inflammatory state. The activation of platelets reacting to tissue damage initiates most healing sequences. The use of activated platelets in the form or platelet-rich plasma (PRP) and/or platelet-rich fibrin (PRF) applied to a clean wound base has been associated with improved wound healing outcomes for bony and soft tissues, especially when associated with standard of care (SOC), including supporting underlying medical conditions, improved perfusion and o…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 1\. Male or female ≥ 18≤ 80 years of age 2. Chronic wounds present for at least thirty (30) days meeting classification as, mild to moderate severity, open exuding wound, including, leg ulcer, pressure ulcer, or mechanically or surgically debrided. 3\. Located in any anatomical location on the body. 4. If more than one non-healing wound is present, an index wound will be selected ≥ 1.0 cm2 size and less than or equal to 25.0 cm2. 5\. If the wound is in an ulcer cluster the dominant ulcer will be selected, with at least 2.0 cm2 between the index wound and other woun…
Interventions
- DevicePlatelet-rich fibrin (PRF)
Standard of Care will include- 1. Nutritional Supplementation using 14 days Juven(R) 2. Wound Cleansing and Debridement 3. Mild to Moderate Compression as needed for edema Control 4. Off-loading as needed (foot gear, chair cushions, bed mattresses) 5. Antimicrobial Dressings as needed 6. Edema Control 7. Negative Pressure Wound Therapy- as needed 8. Collagen dressings as indicated 9. Optimized perfusion/oxygenation 10. Treated Underlying Medical Conditions
Locations (3)
- MCR Health-Advanced Specialty Institute (ASI)Bradenton, Florida
- San Antonio Vascular and Endovascular Clinic (SAVE)San Antonio, Texas
- The San Antonio Vascular and Endovascular Clinic (SAVE)San Antonio, Texas