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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.

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 data supports the effectiveness of the treatment Suprathel® for burns?

A study compared Suprathel® to another treatment, Mepilex® Ag, for treating partial-thickness burns in children, suggesting Suprathel® could be a suitable alternative. ^{1 2 3 4 5}

How is the treatment Suprathel® different from other treatments for burns?

Suprathel® is a wound and burn dressing that can be an alternative to Mepilex® Ag for treating partial-thickness burns, particularly in children. It is unique because it is designed to mimic the properties of human skin, providing a moist environment that supports healing and reduces pain. ^{1 4 6 7 8}

Research Team

Rodney Chan, MD

Principal Investigator

Metis Foundation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

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

Suprathel® or Mepilex® Ag for treatment of partial thickness burns in children: A case control study. [2023]

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

Enhanced sensitivity of human colon tumor cell lines in vitro in response to thermochemoimmunotherapy. [2022]

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

Hyperthermic antiblastic perfusion for the treatment of soft tissue limb sarcoma. [2020]

4. United States 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. [2022]

5. Greece 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. [2018]

6. United States 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. [2013]

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

[Anti-blastic hyperthermic perfusion in the treatment of melanoma of the extremities in the loco-regional diffusion phase]. [2019]

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

Hyperthermic isolated limb perfusion with tumor necrosis factor-alpha and melphalan in advanced soft-tissue sarcomas: histopathological considerations. [2023]