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

July 11, 2024 updated by: St Elizabeth Healthcare

Fish Skin Grafts With Platelet-rich Plasma Compared to Fish Skin Grafts for Chronic Wound Healing: Randomized, Prospective Trial

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • St. Elizabeth Healthcare Edgewood

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Xenograft only
The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied without the application of PRP.
Experimental: Xenograft and PRP
The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied with the application of PRP.
Other: Platelet Rich Plasma
Platelet rich plasma will be applied to assess rate of wound healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to wound being deemed healed or 6 months
Time Frame: 6 months
Assessed by time, surface area of wound, wound volume and relative surface size
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound quality of life
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Elizabeth Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELD.001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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