Suprathel® for Burns

Overseen By Kristin Anselmo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Metis Foundation

Must not be taking: Steroids, Anticoagulants, Immunosuppressants

Disqualifiers: Pregnancy, Infection, Prisoners, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Suprathel®, a special wound dressing, to determine if it heals burns more effectively than usual care. Researchers aim to find out if Suprathel® can reduce the need for skin grafts, lessen pain, lower infection risk, and decrease scarring and costs. They seek participants with partial-thickness burns from friction, hot liquids, or flames, excluding those with burns on the face, neck, scalp, or feet. Eligible participants should have burns covering at least 2% of their body but no more than 5% of third-degree burns. Those meeting these conditions and willing to sign consent may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to the understanding of a potentially better treatment for burn healing.

Will I have to stop taking my current medications?

The trial requires that participants not be on steroids, chronic anticoagulants (blood thinners), or immune suppressive treatments. If you are taking any of these, you may need to stop before joining the trial.

What prior data suggests that Suprathel® is safe for burn treatment?

Research has shown that Suprathel® is generally safe for treating burns and helps reduce pain and scarring. A 10-year study on children with burns found Suprathel effective and easy to use. Another study compared Suprathel with a similar dressing, finding both safe and effective in promoting quick wound healing after cleaning.

Overall, Suprathel is well-tolerated, with no major safety issues reported. Proper wound cleaning is essential for Suprathel to work effectively. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Suprathel® is unique because it's a synthetic wound dressing designed to mimic the skin's natural barrier, which can be especially beneficial for burn treatment. Traditional burn care often involves dressings that need frequent changes, causing discomfort and potential disruption to healing. Suprathel® stands out by offering a more comfortable and potentially longer-lasting solution as it adheres to the wound and gradually degrades, reducing the need for frequent dressing changes. Researchers are excited about its potential to improve patient comfort and support faster healing compared to standard care options.

What evidence suggests that Suprathel® is effective for burns?

Studies have shown that Suprathel® effectively treats burns affecting only the top skin layers. Research indicates that this treatment reduces pain and improves wound healing. In one study, Suprathel® adhered well to wounds, aiding healing. Another study found it lowers the chances of scarring and infection. Overall, Suprathel® shows promise in managing burns and might reduce the need for skin grafts. In this trial, participants will receive either the Suprathel® dressing or the standard burn treatment, allowing for a direct comparison of their effectiveness. ^{1 2 3 4 5}

Who Is on the Research Team?

Rodney Chan, MD

Principal Investigator

Metis Foundation

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with partial thickness burns from friction, contact, scalding or flame. They must be able to consent and have a burn area of at least 2% but less than 5% of their body excluding face, neck, scalp, and feet.

Inclusion Criteria

I have burns caused by friction, hot liquids, direct contact, or flames.

Subject is able and willing to sign Informed Consent or via legally authorized representative

I have burns on more than 2% of my body, not including my face, neck, scalp, or feet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Application of Suprathel® dressing or Standard of Care to burn wounds, maintained according to protocol

6 weeks

Weekly visits

Follow-up

Participants are monitored for wound infection rate, wound closure, and scar maturation

52 weeks

Visits at 2, 3, 6 weeks, and mid to long term follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Suprathel®

Trial Overview The study tests if Suprathel®, a synthetic wound dressing, can reduce the need for skin grafts in burn patients compared to standard care. It also examines pain reduction, infection rates, workload on providers, scar development and costs.

How Is the Trial Designed?

Group I: Suprathel® dressing Experimental Treatment 1 Intervention

The Suprathel® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use

Group II: Standard of Care Active Control 1 Intervention

The Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement.

Suprathel® is already approved in United States for the following indications:

Approved in United States as Suprathel Wound and Burn Dressing for:

• Temporary coverage of non-infected skin defects
• Partial and full thickness wounds
• Pressure and venous ulcers
• Ulcers caused by mixed vascular etiologies
• Venous stasis and diabetic ulcers
• 1st and 2nd degree burns
• Partial thickness burns
• Cuts and abrasions
• Acute wounds
• Trauma wounds
• Surgical wounds
• Superficial wounds
• Grafted wounds and donor sites

Who Is Running the Clinical Trial?

The Metis Foundation

Lead Sponsor

Trials

13

Recruited

750+

Published Research Related to This Trial

In a study of 30 patients with locally advanced extremity soft-tissue sarcomas, hyperthermic isolated limb perfusion using tumor necrosis factor-alpha and melphalan resulted in significant tumor necrosis, with over 90% necrosis observed in 8 cases and 60-90% in 17 cases, indicating its efficacy as an induction treatment for limb-sparing surgery.

The histological analysis revealed that the best responses were seen in distally located tumors, particularly malignant fibrous histiocytoma, while desmoid tumors showed less necrosis, suggesting that tumor type and location may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperthermic isolated limb perfusion with tumor necrosis factor-alpha and melphalan in advanced soft-tissue sarcomas: histopathological considerations. Issakov, J., Merimsky, O., Gutman, M., et al.[2023]

In a study of 58 children with partial-thickness scalds, both Suprathel® and Mepilex® Ag dressings showed similar healing outcomes, with no significant differences in healing time, infection rates, or need for operations.

Both treatment groups required an average of four dressing changes, indicating that Suprathel® can be considered an adequate alternative to Mepilex® Ag for this type of injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suprathel® or Mepilex® Ag for treatment of partial thickness burns in children: A case control study. Karlsson, M., Steinvall, I., Elmasry, M.[2023]

In a study of 80 patients with high-grade soft tissue sarcoma, hyperthermic antiblastic perfusion (H.A.P.) followed by radiotherapy led to a 100% conservative surgery rate and a 94% loco-regional control rate, indicating its effectiveness as part of a multimodal treatment approach.

The overall survival rate was 70%, and the treatment protocol was identified as a significant prognostic factor, highlighting the importance of combining therapies for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperthermic antiblastic perfusion for the treatment of soft tissue limb sarcoma. Di Filippo, F., Giannarelli, D., Botti, C., et al.[2020]

In a study of 34 patients with locally advanced extremity soft-tissue sarcomas, the combination of hyperthermic isolated limb perfusion (HILP) with TNF-alpha, IFN-gamma, and melphalan followed by adjuvant external beam radiotherapy (EBRT) resulted in no local recurrences, while 26% of patients in the HILP-only group experienced local recurrences.

The addition of EBRT did not increase treatment-related morbidity, suggesting that this combined approach is both effective in controlling local tumors and safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of external beam radiotherapy after hyperthermic isolated limb perfusion with TNF-alpha and melphalan for limb-saving treatment in locally advanced extremity soft-tissue sarcoma. Olieman, AF., Pras, E., van Ginkel, RJ., et al.[2022]

The study demonstrated that combining hyperthermia with SN-38, the active metabolite of CPT-11, significantly reduces the survival of esophageal squamous carcinoma cells compared to using SN-38 alone.

This combination therapy shows a synergistic anti-tumor effect, suggesting it could be an effective treatment option for patients with squamous cell carcinoma of the esophagus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental evidence for the efficacy of combined therapy of CPT-11 and hyperthermia for squamous cell carcinoma of the esophagus. Nozoe, T., Yasuda, M., Honda, M., et al.[2018]

In a Phase I trial involving 27 patients with peritoneal carcinomatosis, continuous hyperthermic peritoneal perfusion (CHPP) with cisplatin and TNF showed no operative or treatment-related mortality, indicating a favorable safety profile for this treatment approach.

The study established a maximum tolerated dose (MTD) of 250 mg/m2 for cisplatin and 0.1 mg/L for TNF, with significant increases in drug concentration in the peritoneal area compared to plasma, suggesting effective localized delivery of these agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I trial of continuous hyperthermic peritoneal perfusion with tumor necrosis factor and cisplatin in the treatment of peritoneal carcinomatosis. Bartlett, DL., Buell, JF., Libutti, SK., et al.[2013]

In a study of three human colon tumor cell lines (DLD-1, HCT-15, and HT-29), the combination of carboplatin, recombinant human TNF, and hyperthermia significantly enhanced cytotoxic effects, particularly in HCT-15 cells, which were sensitive to TNF alone.

The triple treatment approach led to a 3-4 log decrease in cell survival, suggesting it could effectively overcome resistance to single or dual treatment modalities in these tumor cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced sensitivity of human colon tumor cell lines in vitro in response to thermochemoimmunotherapy. Klostergaard, J., Leroux, E., Siddik, ZH., et al.[2022]

Hyperthermic antiblastic perfusion (HAP) is an effective treatment for loco-regional spreading limb melanoma, allowing for high doses of chemotherapy while isolating the limb from systemic circulation, leading to improved survival rates for different disease stages.

Combining tumor necrosis factor (TNF) with Melphalan and hyperthermia shows promising results, particularly in patients with bulky tumors, achieving a complete tumor response rate of 67% compared to 20% with Melphalan and hyperthermia alone, although further confirmation through larger trials is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Anti-blastic hyperthermic perfusion in the treatment of melanoma of the extremities in the loco-regional diffusion phase]. Di Filippo, F., Garinei, R., Anzà, M., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5533852/

Usability and effectiveness of Suprathel® in partial ... Suprathel provides potential advantages regarding pain and scar formation, but extensive wound debridement is needed to achieve adequate adherence.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0305417925000804

Suprathel's usability and effectiveness for the treatment of ... The use of Suprathel as epidermal dressing for treatment of partial thickness burns in the paediatric population demonstrates favourable adherence to the wound ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10603925/

Comparative Clinical Study of Suprathel® and Jelonet ... Its application to partial-thickness burn wounds showed a good impact on wound healing and pain reduction [17]. Suprathel® was also shown to be ...

4. digital.sandiego.edu digital.sandiego.edu/cgi/viewcontent.cgi?article=1258&context=dnp

A COMPARISON OF SUPRATHEL BURN DRESSING VS ... 27 patients developed hypertrophic scarring (11.7%), the rate of infection was 3.8% (8/229), and failure or progression to full thickness in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05462860

Suprathel® Use During Prolonged Field Care to Promote ... The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting.