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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a fish skin graft can accelerate healing after surgery, potentially reducing hospital stays. It targets individuals with large surgical wounds (at least 40 square centimeters) requiring surgical debridement. The trial includes two groups: one using only vacuum-assisted closure and the other using both vacuum-assisted closure and the fish skin graft. Individuals allergic to fish or unable to commit to follow-ups for up to a year should not participate. As an unphased trial, this study provides a unique opportunity to explore innovative healing methods that could enhance recovery experiences.

Will I have to stop taking my current medications?

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

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

Research has shown that fish skin grafts can help heal wounds. In one study with 114 patients, only one person experienced a negative reaction to the fish skin grafts, indicating the treatment is usually well-tolerated.

Other studies confirm the safety of fish skin grafts. Reports from real-world use demonstrate their safety and effectiveness in treating wounds, including diabetic foot ulcers.

Overall, the evidence suggests fish skin grafts are safe for people. While reactions can occur, they appear to be rare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fish Skin Graft (FSG) is unique because it harnesses the healing properties of fish skin, which is rich in omega-3 fatty acids, to treat surgical wounds. Unlike standard treatments like traditional skin grafts or vacuum-assisted closure alone, FSG can promote faster healing and reduce inflammation. Researchers are excited about FSG because it offers a natural and potentially more effective alternative, with the added benefit of being less invasive and possibly reducing the risk of infection.

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

Research has shown that fish skin grafts help wounds heal faster. In this trial, participants in one arm will receive Fish Skin Grafts alongside Vacuum-Assisted Closure. Studies have found that wounds treated with fish skin grafts heal much quicker than those treated with traditional methods like paraffin gauze. For example, one study found that 97.6% of surgical wounds completely closed when treated with fish skin grafts. Another study showed that 44% of diabetic foot ulcers fully healed with fish skin grafts. These results suggest that fish skin grafts could be a promising option for healing surgical wounds. ^{1 3 6 7 8}

Who Is on the Research Team?

Jonah Stulberg, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12452568/

Evaluation of the Efficacy of Fish Skin Grafts as Wound ... All studies showed early wound healing using fish skin grafts; one study showed that wound healing was halved compared to paraffin gauze.

2. facs.org facs.org/for-medical-professionals/news-publications/news-and-articles/acs-brief/december-10-2024-issue/fish-skin-grafts-show-promise-for-improved-diabetic-foot-ulcer-healing/

Fish Skin Grafts Show Promise for Improved Diabetic Foot ... The main outcome of interest was the rate of complete healing at 16 weeks. Healing occurred in 44% of patients treated with fish skin graft and ...

3. 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 ...

4. upderm.com upderm.com/post-mohs-surgical-wounds-treated-with-intact-fish-skin-graft-a-multicenter-analysis/

Post-Mohs Surgical Wounds Treated With Intact Fish Skin ... Over the course of the registry for patients with post-Mohs surgery, 40 of 41 wounds achieved complete wound closure (97.6%), and 1 patient was ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40297994/

Real-world outcomes of acellular fish skin grafts for chronic ... Of 22 patients, 19 (86.4%) showed a mean reduction in WSA of -60.7% ± 143.8% (p = 0.0025); 36.4% of CW were healed. AFSG-related costs were 1232.3 EUR/patient ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06910189

Study Details | NCT06910189 | Use of Fish Skin Graft (FSG ... Study Details | NCT06910189 | Use of Fish Skin Graft (FSG) to Improve Wound Healing and Expedite Discharge at a County Safety-net Hospital | ClinicalTrials.gov.

7. journals.lww.com journals.lww.com/prsgo/fulltext/2023/09000/fish_skin_graft__narrative_review_and_first.32.aspx

Fish Skin Graft: Narrative Review and First Application for .. ... The fish skin graft provides promising results in tissue regeneration and in the management of chronic and acute wounds, pressure ulcers, vascular ulcers, ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1262363625000850

Intact fish skin graft for deep diabetic foot ulcers The primary endpoint was 41.6 % closure rate in IFSG group versus 22.2 % in SOC group (P = 0.0053). In the intent to treat analysis (ITT), there was a ...