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

St Elizabeth Healthcare

Status: Withdrawn

Conditions: Non-healing Wound

Treatments: Other: Platelet Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT05766982

ELD.001

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Xenograft only

No Intervention group

Description:

The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied without the application of PRP.

Xenograft and PRP

Experimental group

Description:

The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied with the application of PRP.

Treatment:

Other: Platelet Rich Plasma