What side effects are associated with this type of intervention?

Common treatments for non-healing wounds, such as xenografts and platelet-rich plasma (PRP), have known side effects. Xenografts can lead to immune reactions, infection, and graft rejection. PRP may cause pain at the injection site, infection, and, rarely, allergic reactions. Combining these treatments aims to enhance healing while monitoring for these potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for non-healing wounds that utilize mechanisms similar to xenografts with PRP. One notable example is the use of Kerecis Omega3, a fish skin graft that provides a natural scaffold for tissue regeneration. While specific FDA approvals for the combination of xenografts and PRP are not detailed, the use of PRP alone has been explored in various clinical settings to enhance wound healing by supplying growth factors. These treatments aim to promote tissue regeneration and accelerate the healing process in chronic, non-healing wounds.

What other types of research exist?

Promising novel alternatives to Xenograft with PRP for non-healing wounds include mesenchymal stem cells (MSCs) and protein replacement therapy with recombinant collagen type VII. MSCs can enhance tissue regeneration and reduce inflammation, while recombinant collagen type VII can restore structural integrity and promote healing.

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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

Must not have

Non-English-speaking patients

Patient with hemoglobin values less than 6.9 g/dL drawn at least 30 days prior to the Kerecis® xenograft surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Summary

This trial compares using an animal skin graft with a special blood component to using the animal skin graft alone for patients with chronic, nonhealing wounds. The animal skin graft provides structure, while the special blood component promotes faster healing. The special blood component is widely used for wound healing in medical care because of the numerous growth factors it contains.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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My hemoglobin level was below 6.9 g/dL at least a month before my planned surgery.

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My wound is caused by an autoimmune disease.

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I am currently receiving chemotherapy or radiation therapy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to wound being deemed healed or 6 months

Secondary study objectives

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 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for non-healing wounds, such as xenografts and platelet-rich plasma (PRP), work through complementary mechanisms. Xenografts provide a scaffold that supports tissue regeneration by mimicking the natural extracellular matrix, facilitating cell attachment, migration, and proliferation. PRP supplies a rich concentration of growth factors and cytokines that enhance cellular processes like angiogenesis, inflammation modulation, and tissue repair. These mechanisms are crucial for non-healing wound patients as they address both the structural and biochemical barriers to effective wound healing, thereby promoting faster and more complete recovery.

The use of platelet-rich products for skin graft donor site healing: a systematic review and meta-analysis.Platelet-rich plasma to treat experimentally-induced skin wounds in animals: A systematic review and meta-analysis.