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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-30

Study Completion Date

2025-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Non-healing Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be a 1:1 randomized controlled trial with parallel group assignment.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Xenograft only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Xenograft and PRP

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

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type OTHER

Platelet rich plasma will be applied to assess rate of wound healing.

Interventions

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Platelet Rich Plasma

Platelet rich plasma will be applied to assess rate of wound healing.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No