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Xenograft

Fish Skin Grafts + PRP for Chronic Wounds

N/A

Waitlist Available

Research Sponsored by St Elizabeth Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is over the age of 18 years

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial looks at using special grafts with healing proteins to help chronic wounds heal faster than with just a graft.

Who is the study for?

This trial is for adults over 18 with chronic, nonhealing wounds sized between roughly 0.8x0.8 inches to about 4x4 inches deep, who are patients of specific doctors and can undergo standard Kerecis® xenograft surgery. It's not for those allergic to fish material, undergoing chemo or radiation therapy, have autoimmune wound origins, don't speak English, or have very low hemoglobin levels.Check my eligibility

What is being tested?

The study is testing the effectiveness of using a fish skin graft (Kerecis® xenograft) with Platelet Rich Plasma (PRP) versus the graft alone on chronic wounds that haven't healed after six weeks of treatment. Participants will be randomly assigned to one of these two approaches.See study design

What are the potential side effects?

Potential side effects may include reactions at the wound site due to sensitivity to fish skin materials in the grafts or complications from PRP therapy such as pain and infection at injection sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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My wound size fits within the specified dimensions.

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I am eligible for surgery using Kerecis® graft.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to wound being deemed healed or 6 months

Secondary outcome measures

Wound quality of life

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Xenograft and PRPExperimental Treatment1 Intervention

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

Group II: Xenograft onlyActive Control1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

St Elizabeth HealthcareLead Sponsor

5 Previous Clinical Trials

14,202 Total Patients Enrolled

Media Library

Kerecis Fish Skin Grafts (Xenograft) Clinical Trial Eligibility Overview. Trial Name: NCT05766982 — N/A

Non Healing Wounds Research Study Groups: Xenograft and PRP, Xenograft only

Non Healing Wounds Clinical Trial 2023: Kerecis Fish Skin Grafts Highlights & Side Effects. Trial Name: NCT05766982 — N/A

Kerecis Fish Skin Grafts (Xenograft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05766982 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts underway for this research endeavor?

"As per the data available on clinicaltrials.gov, this study is no longer seeking participants; it was initially posted on March 1st 2023 and last edited two days later. Although there are no openings for patients in this trial presently, 14 other studies are actively recruiting at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Kerecis Fish Skin Grafts With and Without Platelet Rich Plasma (PRP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05766982.

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