Fish Skin Graft for Surgical Wounds

Overseen By Debbie Lew

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Fish allergy, Incarcerated, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Hospital stay duration

96 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Fish Skin Graft (FSG) for surgical wounds?

Fish Skin Grafts (FSGs) have shown promise in healing various types of wounds, including those from serious infections and in animals, by promoting faster healing and reducing inflammation. They are rich in omega-3, which helps tissue regeneration, and have been successfully used in both adults and children for different wound types, including diabetic foot ulcers and abdominal wall issues. ^{1 2 3 4 5}

Is fish skin graft safe for use in humans?

Fish skin grafts, made from the skin of North Atlantic cod, are considered safe for use in humans. They are cleared by the US Food and Drug Administration and have no known risk of transmitting diseases from fish to humans. These grafts have been used in various clinical applications, showing good safety profiles in both adults and children. ^{2 3 4 5 6}

How is the Fish Skin Graft treatment different from other treatments for surgical wounds?

Fish Skin Graft (FSG) is unique because it is made from the skin of the Atlantic cod and is rich in omega-3, which helps in tissue regeneration and wound healing. Unlike other skin substitutes, it is structurally similar to human skin and does not carry the risk of transmitting diseases from mammals, making it a safe and effective option for wound healing. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to estimate the effect of FSG (Kerecis) on hospital length of stay among adult patients with surgical wounds of at least 40cm2 requiring surgical debridement

Research Team

Jonah Stulberg, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for adults with large surgical wounds (at least 40cm2) needing surgical cleaning. Participants must be willing to follow up for a year but can't join if they're allergic to fish, unlikely to follow up, in police custody, unable to communicate in English or Spanish, or have wounds not requiring surgery.

Inclusion Criteria

Agreeable to follow up period of up to 1 year

I have a large wound (≥ 40cm2) needing surgery to remove damaged tissue.

Exclusion Criteria

Patients with a known allergy or other sensitivity to fish material

Patients who are deemed unlikely to follow up (e.g., patients who live out of state)

Patients in police custody/incarcerated

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fish Skin Graft (FSG) and/or Vacuum-Assisted Closure for wound healing

Hospital stay duration

Follow-up

Participants are monitored for financial toxicity and other outcomes after discharge

12 months

Treatment Details

Interventions

• Fish Skin Graft (FSG)

Trial Overview The study tests whether Fish Skin Grafts (FSG) reduce hospital stays compared to the standard Wound Vacuum-Assisted Closure (VAC) in patients with large surgical wounds. It aims to see if FSG can speed up healing and discharge from a county safety-net hospital.

Participant Groups

Group I: Fish Skin Graft arm and Vacuum-Assisted Closure Experimental Treatment 2 Interventions

Group II: Vacuum-Assisted Closure only Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

In a study involving 94 patients with diabetic foot ulcers, the use of acellular fish skin grafts resulted in a significantly higher healing rate of 63.0% compared to 31.3% for the standard collagen alginate dressing after 12 weeks (P = 0.0036).

Both treatment groups had a similar mean healing time of 7 weeks, but the fish skin graft required a median of 6 applications to achieve healing, indicating its potential as an effective alternative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effect of omega-3-rich fish skin in the treatment of chronic, nonresponsive diabetic foot ulcers: penultimate analysis of a multicenter, prospective, randomized controlled trial. Lullove, EJ., Liden, B., McEneaney, P., 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) 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]

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]

In a study of 15 pediatric patients using a novel acellular fish skin graft (FSG) derived from cod, rapid wound healing was achieved, with 100% wound area coverage and 95% complete healing, significantly reducing the time to engraftment from an average of 21 days to 12 days when combined with negative pressure wound therapy (NPWT).

The use of FSG resulted in shorter operating times (less than 60 minutes), no reported complications or allergic reactions, and excellent pliability of healed wounds, making it a promising and sustainable option for pediatric skin grafting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of acellular intact fish skin grafts in treating acute paediatric wounds during the COVID-19 pandemic: a case series. Ciprandi, G., Kjartansson, H., Grussu, F., et al.[2022]

References

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

Evaluating the effect of omega-3-rich fish skin in the treatment of chronic, nonresponsive diabetic foot ulcers: penultimate analysis of a multicenter, prospective, randomized controlled trial. [2022]

2. 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]

3. 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]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Use of acellular intact fish skin grafts in treating acute paediatric wounds during the COVID-19 pandemic: a case series. [2022]

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

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