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

Sponsor
St Elizabeth Healthcare (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05766982
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
30.1
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Platelet Rich Plasma
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study will be a 1:1 randomized controlled trial with parallel group assignment.This study will be a 1:1 randomized controlled trial with parallel group assignment.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Fish Skin Grafts With Platelet-rich Plasma Compared to Fish Skin Grafts for Chronic Wound Healing: Randomized, Prospective Trial
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Elizabeth Healthcare Edgewood Edgewood Kentucky United States 41017

Sponsors and Collaborators

  • St Elizabeth Healthcare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
St Elizabeth Healthcare
ClinicalTrials.gov Identifier:
NCT05766982
Other Study ID Numbers:
  • ELD.001
First Posted:
Mar 13, 2023
Last Update Posted:
Mar 16, 2023
Last Verified:
Mar 1, 2023
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
Keywords provided by St Elizabeth Healthcare
xenograft
PRP
platelet rich plasma
Additional relevant MeSH terms:
Ichthyosis

Study Results

No Results Posted as of Mar 16, 2023