Non-healing Wound
Conditions
Keywords
xenograft, PRP, platelet rich plasma
Brief summary
This prospective, randomized pilot study compares the use of a xenograft with PRP to a xenograft alone for chronic, nonhealing wounds.
Interventions
OTHERPlatelet Rich Plasma
Platelet rich plasma will be applied to assess rate of wound healing.
Sponsors
St Elizabeth Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study will be a 1:1 randomized controlled trial with parallel group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed