Fish Skin Grafts + PRP for Chronic Wounds

Overseen By Richard Harm

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St Elizabeth Healthcare

Disqualifiers: Low hemoglobin, Fish allergy, Chemotherapy, Radiation, Autoimmune wound, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to heal chronic, nonhealing wounds using Kerecis Fish Skin Grafts. Researchers aim to determine if adding PRP (platelet-rich plasma) to the fish skin grafts is more effective than using the grafts alone. People with wounds that haven't healed for over six weeks and who are patients of certain doctors may qualify. The goal is to discover a more effective treatment for these persistent wounds. As an unphased trial, this study allows patients to contribute to innovative research that could lead to improved treatments for chronic wounds.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are undergoing chemotherapy or radiation therapy, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Kerecis fish skin grafts are generally safe for treating wounds. These grafts, made from fish skin, promote new tissue growth. Importantly, no known risk of virus transmission exists with these grafts, making them a safe choice for wound care.

Similarly, researchers have studied platelet-rich plasma (PRP) for its role in healing wounds. Studies indicate that PRP is safe and can speed up healing in chronic wounds. PRP uses a concentrated form of blood platelets, which aid in the healing process.

Both treatments are well-tolerated by patients and have shown positive safety results in past studies. For those considering participation in a trial with these treatments, available evidence suggests they are safe options for managing chronic wounds. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for chronic wounds, like traditional skin grafts and synthetic dressings, Kerecis Fish Skin Grafts are derived from fish skin rich in Omega-3 fatty acids. Researchers are excited about these treatments because fish skin grafts promote faster healing and reduce inflammation naturally. Additionally, when combined with platelet-rich plasma (PRP), the fish skin grafts could enhance tissue regeneration and improve outcomes further. This unique combination leverages the natural properties of fish skin and the growth factors in PRP, offering a potentially more effective and biologically friendly approach to chronic wound care.

What evidence suggests that this trial's treatments could be effective for chronic wounds?

Studies have shown that Kerecis fish skin grafts can accelerate the healing of chronic wounds. Research indicates that these Omega-3-rich grafts helped diabetic foot wounds heal faster than other treatments. In this trial, some participants will receive the Kerecis xenograft alone, while others will receive it combined with platelet-rich plasma (PRP), which supports tissue repair. Early findings suggest that PRP with the grafts might enhance healing by creating a supportive environment for skin regeneration. Overall, the treatment shows promising potential for hard-to-heal wounds. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am over 18 years old.

My wound has not healed after 6 weeks of treatment.

You are a patient of Dr. Eldridge, Dr. Glenn, or Dr. Worley.

Exclusion Criteria

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

My wound is caused by an autoimmune disease.

Patient with a known allergy or other sensitivity to fish material

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a xenograft with PRP or a xenograft alone for chronic wound healing

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kerecis Fish Skin Grafts
• Platelet Rich Plasma

Trial Overview 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.

How Is the Trial Designed?

Group I: Xenograft and PRP Experimental Treatment 1 Intervention

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

Group II: Xenograft only Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

St Elizabeth Healthcare

Lead Sponsor

Trials

6

Recruited

14,900+

Published Research Related to This Trial

In a study of eight diabetic patients with postoperative foot wounds, the use of an intact fish skin graft rich in omega-3 resulted in over 84.9% reduction in wound area for wounds less than three months old after six weeks of treatment.

No infections or adverse skin reactions were reported, indicating that the fish skin graft is safe and may be an effective adjunct treatment for accelerating healing in diabetic foot wounds, especially when applied early.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of diabetic foot wounds with acellular fish skin graft rich in omega-3: a prospective evaluation. Woodrow, T., Chant, T., Chant, H.[2019]

The Kerecis™ Omega3 Wound matrix, derived from fish skin, was used to treat 25 complicated wounds in 23 patients, showing effectiveness in promoting healing where conventional treatments had failed.

Patients experienced a reduction in analgesic intake after starting treatment with the Omega3 Wound matrix, suggesting potential pain-relieving benefits alongside its wound healing properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The marine Omega3 wound matrix for treatment of complicated wounds: A multicenter experience report. Dorweiler, B., Trinh, TT., Dünschede, F., et al.[2022]

Acellular fish skin grafts (FSGs) derived from Atlantic cod are effective for wound healing, supporting tissue regeneration and revascularization, and are safe as they do not transmit known diseases to humans.

FSGs are the only acellular dermal matrix products not derived from mammals and have been successfully used in both adult and pediatric patients, including a case where a 7-year-old boy's abdominal wall wound healed effectively with FSG treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fish Skin Graft: Narrative Review and First Application for Abdominal Wall Dehiscence in Children. Di Mitri, M., Di Carmine, A., Thomas, E., et al.[2023]

Intact fish skin grafts (iFSGs) showed promising results in promoting wound granulation and providing pain relief in two patients with extensive leg ulcers following necrotizing fasciitis, with no complications or allergic reactions reported.

The application of iFSGs was easy and led to excellent functional and cosmetic outcomes after subsequent autologous skin grafting, suggesting their potential as a valuable treatment option for necrotizing fasciitis and possibly other wound types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Intact Fish Skin Grafts in the Treatment of Necrotizing Fasciitis of the Leg: Early Clinical Experience and Literature Review on Indications for Intact Fish Skin Grafts. Dueppers, P., Bozalka, R., Kopp, R., et al.[2023]

Acellular fish skin grafts (FSGs) were used successfully on 13 dogs and 4 cats with complex wounds, leading to complete healing in most cases without any reported adverse events.

The median time for wounds to heal after the first FSG application was 71 days, and the application process was straightforward, requiring no special training or equipment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular fish skin grafts for the management of wounds in dogs and cats: 17 cases (2019-2021). Mauer, ES., Maxwell, EA., Cocca, CJ., et al.[2022]

Citations

1. kerecis.com kerecis.com/kerecis-fish-skin-technology-to-make-a-splash-at-sawc-fall-2025/

Kerecis Fish-Skin Technology to Make a Splash at SAWC ... Kerecis highlights intact fish-skin grafts, offering clinicians sustainable, science-backed solutions for wound and tissue repair care.

2. kerecis.com kerecis.com/peer-reviewed-article-in-wounds-examines-efficacy-of-kerecis-fish-skin-treatment-for-diabetic-foot-wounds/

Peer-Reviewed Article in “Wounds” Examines Efficacy of ... The three-year retrospective study evaluated the efficacy of the Kerecis Omega3 rich fish skin used as grafts in the treatment of full-thickness diabetic foot ...

3. ctv.veeva.com ctv.veeva.com/study/kerecis-fish-skin-grafts-with-and-without-platelet-rich-plasma-prp

Kerecis Fish Skin Grafts With and Without Platelet Rich ... This prospective, randomized pilot study compares the use of a xenograft with PRP to a xenograft alone for chronic, nonhealing wounds.

4. withpower.com withpower.com/trial/phase-ichthyosis-2-2023-24161

Fish Skin Grafts + PRP for Chronic Wounds Fish skin grafts, like Kerecis, have been used safely in various studies for wound healing, including burns and diabetic foot wounds, showing faster healing and ...

5. kerecis.com kerecis.com/new-study-2021/

New Study Finds Statistically Significantly Faster Healing ... A study in Wounds reports statistically significantly higher healing rates for DFUs treated with Kerecis Omega3 fish skin compared to ...

6. kerecis.com kerecis.com/marigen/

MariGen MariGen is intact fish skin which is used to support tissue regeneration in surgical, traumatic, and chronic wounds. Because there is no known risk of viral ...

7. kerecis.com kerecis.com/fish-skin-for-wound-healing/

Fish Skin for Wound Healing The Only Intact Fish Skin Graft: Managing Challenging Chronic and Acute Wounds. · Backed by robust clinical data including the landmark Odinn Study · Included in ...

8. kerecis.com kerecis.com/marigen-us-product-details-and-resources/

MariGen - U.S. Product Details and Resources Kerecis MariGen is intact fish skin for the management of chronic wounds such as diabetic wounds, pressure ulcers, vascular ulcers, and draining wounds ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K190528.pdf

K190528 Trade/Device Name - accessdata.fda.gov The subject device is obtained from fish skin via standardized controlled GMP manufacturing process and supplied in terminally sterile packaging ...

10. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39764&ver=8&keyword=valve%20replacement&keywordType=any&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1

Skin Substitute Grafts/Cellular and Tissue-Based Products ... Fish skin grafts with omega-3 for treatment of chronic wounds: exploring the role of omega-3 fatty acids in wound healing and a review of clinical healing ...