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

Trial Summary

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.

What data supports the effectiveness of the treatment Kerecis Fish Skin Grafts and PRP for chronic wounds?

Research shows that Kerecis Fish Skin Grafts help wounds heal faster and with less scarring, as seen in burn patients and those with diabetic foot wounds. The fish skin's unique structure and omega-3 content contribute to its effectiveness in promoting healing and reducing inflammation. ^{1 2 3 4 5}

Is the combination of fish skin grafts and PRP safe for treating 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 good outcomes without significant safety concerns. However, specific safety data on the combination with PRP is not detailed in the available studies. ^{1 3 4 5 6}

How is the treatment with Kerecis Fish Skin Grafts unique for chronic wounds?

Kerecis Fish Skin Grafts are unique because they are made from the skin of Atlantic cod, which is rich in omega-3 and supports faster wound healing by promoting tissue regeneration and reducing inflammation. Unlike other treatments, these grafts are not derived from mammals, reducing the risk of disease transmission, and they have shown superior healing compared to traditional options like bovine collagen grafts. ^{1 5 7 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Wound healing ability of acellular fish skin and bovine collagen grafts for split-thickness donor sites in burn patients: Characterization of acellular grafts and clinical application. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Acellular fish skin may be used to facilitate wound healing following wide surgical tumor excision in dogs: a prospective case series. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

The marine Omega3 wound matrix for treatment of complicated wounds: A multicenter experience report. [2022]

5. Switzerland 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Accelerated Wound Closure of Deep Partial Thickness Burns with Acellular Fish Skin Graft. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Fish Skin Graft: Narrative Review and First Application for Abdominal Wall Dehiscence in Children. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Acellular fish skin grafts for the management of wounds in dogs and cats: 17 cases (2019-2021). [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Fish Skin Grafts Versus Alternative Wound Dressings in Wound Care: A Systematic Review of the Literature. [2023]