BTM vs Human Cadaveric Allograft for Hidradenitis Suppurativa

Overseen By Austin Price, BS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Joseph M. Still Research Foundation, Inc.

Disqualifiers: Cardiac risk, Autoimmune, Cancer, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial compares a new wound treatment with standard methods in patients with Hidradenitis suppurativa. The new treatment helps wounds heal by providing a temporary structure for new tissue growth, while standard methods use traditional wound care techniques. The new treatment has shown positive outcomes in healing burns and plastic surgery wounds, but its effectiveness in diabetic foot wounds has not yet been established.

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.

What data supports the effectiveness of the treatment Human Cadaveric Allograft, Cadaver Skin, Allograft, Homograft, NovaSorb® BTM, NovoSorb BTM, Biodegradable Temporizing Matrix for Hidradenitis Suppurativa?

The research on a similar treatment using a co-graft of Acellular Dermal Matrix and Split Thickness Skin Graft for Hidradenitis Suppurativa showed promising results, with fast wound closure and good scar appearance, suggesting potential effectiveness for reconstructive surgery in this condition. ^{1 2 3 4 5}

Is NovoSorb BTM safe for use in humans?

NovoSorb BTM has been studied for safety in various conditions, including burns and complex wounds. Research shows it is generally safe, with minimal harmful effects on human skin cells and no toxic effects observed in animal studies. ^{6 7 8 9 10}

How does the treatment with NovoSorb BTM differ from other treatments for hidradenitis suppurativa?

NovoSorb BTM is unique because it is a synthetic skin substitute that helps regenerate skin by creating a new layer (neo-dermis) before applying a skin graft, making it suitable for complex wounds that are difficult to treat with traditional methods. ^{6 7 8 11 12}

Research Team

Zaheed Hassan, MD

Principal Investigator

JOSEPH M STILL RESEARCH FOUNDATION

Eligibility Criteria

This trial is for adults with severe Hidradenitis Suppurativa requiring surgery, who can follow the study plan and are treated at specific centers. It's not for those with serious heart issues, autoimmune diseases, cancer, organ failure, bleeding risks or extreme obesity (BMI > 40).

Inclusion Criteria

I have severe HS needing major surgery.

Subject or their legally authorized representative is able to provide informed consent

I have chronic Hidradenitis Suppurativa needing major surgery in areas like groin or underarms.

Exclusion Criteria

I do not have any autoimmune diseases, other cancers, or organ failures that would stop me from being in the study.

Anticipates a level of non-compliance

I have conditions that could slow down my wound healing.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical excision and receive either BTM or SOC treatment on their wounds, followed by dressing and negative pressure wound therapy as needed.

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for wound healing, infection, and graft take, with assessments continuing until the wound is ready for grafting.

6 weeks

Weekly visits (in-person)

Long-term Follow-up

Long-term follow-up to assess scar quality, range of motion, and recurrence of hidradenitis suppurativa.

12 months

Visits at 3, 6, and 12 months

Treatment Details

Interventions

• Human Cadaveric Allograft (Procedure)
• NovaSorb® BTM (Temporizing Matrix)

Trial Overview The study compares two methods of wound treatment after HS surgery: one uses a biodegradable matrix called NovoSorb® BTM and standard care; the other uses human cadaver skin grafts. There will be 10 patients in total, split into two groups.

Participant Groups

Group I: NovoSorb® BTM Experimental Treatment 1 Intervention

Group II: Human Cadaver Allograft Active Control 1 Intervention

Human Cadaveric Allograft is already approved in Canada for the following indications:

Approved in Canada as Human Cadaveric Allograft for:

• Burns
• Wound care
• Skin reconstruction

Who Is Running the Clinical Trial?

Joseph M. Still Research Foundation, Inc.

Lead Sponsor

Trials

9

Recruited

360+

PolyNovo Biomaterials Pty Ltd.

Industry Sponsor

Trials

4

Recruited

200+

Findings from Research

A new surgical method using a co-graft of Acellular Dermal Matrix (ADM) and split-thickness skin graft (STSG) showed promising results for wound closure in patients with hidradenitis suppurativa, achieving fast healing and good aesthetic outcomes.

This preliminary study, based on two cases, suggests that this innovative approach could improve surgical treatment options for hidradenitis suppurativa, but further research is needed to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-Graft of Acellular Dermal Matrix and Split Thickness Skin Graft-A New Reconstructive Surgical Method in the Treatment of Hidradenitis Suppurativa. Gierek, M., Łabuś, W., Słaboń, A., et al.[2022]

In a study of 94 patients with hidradenitis suppurativa who switched from the original adalimumab (ADAO) to the biosimilar ABP 501, 33.3% experienced adverse events or loss of response within 12 to 14 weeks after the switch.

The findings suggest that switching from ADAO to ABP 501 can significantly impact treatment effectiveness, particularly for patients on remission maintenance therapy, indicating that such switches should be approached with caution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Switching from Adalimumab Originator to Biosimilar in Patients with Hidradenitis Suppurativa Results in Losses of Response-Data from the German HS Registry HSBest. Kirsten, N., Ohm, F., Gehrdau, K., et al.[2022]

In a study of 37 patients with hidradenitis suppurativa, switching from the adalimumab originator to its biosimilar showed no significant differences in clinical response over 12 months, indicating that the biosimilar is an effective alternative.

However, the study revealed a high discontinuation rate of 43.2%, primarily due to severe injection site pain, suggesting that patient compliance may be a concern with biosimilars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Switching from adalimumab originator to biosimilars in hidradenitis suppurativa: What's beyond cost-effectiveness? Roccuzzo, G., Rozzo, G., Burzi, L., et al.[2022]

In a study involving six patients with chronic gluteal hidradenitis suppurativa, a novel 'reused' skin graft technique was successfully employed, allowing for reconstruction of large skin defects using the patient's own resected skin, thus avoiding the need for a separate skin donor site.

Postoperative complications were generally minor, and importantly, no patients experienced functional disabilities or recurrence of HS during the follow-up period of 8 to 36 months, indicating the efficacy and safety of this alternative grafting method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of chronic gluteal hidradenitis suppurativa: reused skin graft technique. Kuo, HW., Ohara, K.[2022]

In a multicenter study involving 30 patients with deep burn injuries, the synthetic polyurethane dermal template (NovoSorb® BTM) demonstrated a high mean split skin graft take of 81.9% and a BTM take of 88.6%, indicating effective integration and performance as a dermal substitute.

The study also showed that BTM could integrate successfully even in the presence of infection signs, and scar quality improved over time, highlighting its safety and potential benefits in burn treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound healing and dermal regeneration in severe burn patients treated with NovoSorb® Biodegradable Temporising Matrix: A prospective clinical study. Lo, CH., Brown, JN., Dantzer, EJG., et al.[2022]

NovoSorb® Biodegradable Temporising Matrix (BTM) has been identified as a reliable treatment option for complex and chronic wounds, particularly beneficial for patients with multiple co-morbidities and infected wounds, based on a retrospective analysis of a single-center study.

While the initial results are promising, indicating BTM's versatility in reconstructive surgery, further research is needed to evaluate long-term outcomes and explore additional clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Complex Wounds with NovoSorb® Biodegradable Temporising Matrix (BTM)-A Retrospective Analysis of Clinical Outcomes. Schlottmann, F., Obed, D., Bingöl, AS., et al.[2022]

In a study of 15 patients who had dermal reconstruction using the NovoSorb® Biodegradable Temporizing Matrix (BTM) for at least 18 months, the long-term scar quality was rated positively by both patients and observers, indicating effective outcomes.

The study found no adverse events or complications associated with the use of BTM, suggesting it is a safe option for dermal repair in patients with significant skin loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term scarring outcomes and safety of patients treated with NovoSorbⓇ Biodegradable Temporizing Matrix (BTM): An observational cohort study. Lo, CH., Wagstaff, MJD., Barker, TM., et al.[2023]

The study found that three variants of NovoSorb, a biodegradable polyurethane, are biocompatible and safe for use as dermal scaffolds, showing minimal cytotoxic effects on human skin cells and no systemic toxicity in rat models.

NovoSorb demonstrated effective integration and healing in a sheep model, providing a promising foundation for a two-stage burn treatment strategy that stabilizes wounds and supports skin regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a novel biodegradable polymer for the generation of a dermal matrix. Li, A., Dearman, BL., Crompton, KE., et al.[2019]

The NovoSorb® Biodegradable Temporising Matrix (BTM) is a synthetic dermal matrix that effectively aids in the reconstruction of complex wounds, including deep dermal burns and chronic ulcers, through a two-stage application process.

BTM serves as a valuable tool in wound management, allowing for easier reconstruction of challenging wounds that might otherwise require more invasive procedures, making it an important option in the reconstructive ladder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novosorb® Biodegradable Temporising Matrix (BTM) and its Applications. Lim, P., Li, H., Ng, S.[2023]

The Biodegradable Temporising Matrix (BTM) is a promising skin substitute that can effectively manage complex wounds, such as those resulting from extravasation injuries, by promoting granulation and neo-dermis formation.

In this case study, the use of BTM allowed for a successful split-thickness skin graft application, resulting in pliable skin and reducing the risk of complications like tendon tethering and joint contracture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel use for the biodegradable temporizing matrix. Frost, SR., Deodhar, A., Offer, GJ.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Co-Graft of Acellular Dermal Matrix and Split Thickness Skin Graft-A New Reconstructive Surgical Method in the Treatment of Hidradenitis Suppurativa. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Switching from Adalimumab Originator to Biosimilar in Patients with Hidradenitis Suppurativa Results in Losses of Response-Data from the German HS Registry HSBest. [2022]

3. Iran pubmed.ncbi.nlm.nih.gov

Comparison of Split Thickness Skin Grafts and Flaps in Bilateral Chronic Axillary Hidradenitis Suppurativa. [2020]

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

Switching from adalimumab originator to biosimilars in hidradenitis suppurativa: What's beyond cost-effectiveness? [2022]

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

Surgical treatment of chronic gluteal hidradenitis suppurativa: reused skin graft technique. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Wound healing and dermal regeneration in severe burn patients treated with NovoSorb® Biodegradable Temporising Matrix: A prospective clinical study. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of Complex Wounds with NovoSorb® Biodegradable Temporising Matrix (BTM)-A Retrospective Analysis of Clinical Outcomes. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term scarring outcomes and safety of patients treated with NovoSorbⓇ Biodegradable Temporizing Matrix (BTM): An observational cohort study. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A consecutive case series of defects reconstructed using NovoSorbⓇ Biodegradable Temporising Matrix: Initial experience and early results. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of a novel biodegradable polymer for the generation of a dermal matrix. [2019]

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

Novosorb® Biodegradable Temporising Matrix (BTM) and its Applications. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

A novel use for the biodegradable temporizing matrix. [2022]