BTM vs Human Cadaveric Allograft for Hidradenitis Suppurativa

Overseen By Joan Wilson, MSN, MHA, RN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Joseph M. Still Research Foundation, Inc.

Disqualifiers: Cardiac risk, Autoimmune, Cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for hidradenitis suppurativa, a skin condition causing painful lumps under the skin. Researchers compare a synthetic product, NovaSorb® BTM, with a human cadaveric allograft (a transplant from a donor). The goal is to determine which treatment improves wound healing after surgery. This trial may suit individuals with severe hidradenitis suppurativa requiring surgery, especially those treated at the Joseph M. Still Burn Center or Advanced Wound Clinic. As a Phase 4 trial, the treatments have FDA approval and proven effectiveness, and this research aims to understand how they benefit more patients.

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 is the safety track record for these treatments?

Research shows that NovoSorb® BTM is generally safe for treating complex wounds. Studies indicate it has low infection rates and few side effects, meaning most patients tolerate it well.

Specific safety data for the Human Cadaveric Allograft isn't available in the sources. However, it is widely used in medical procedures and is generally considered safe.

NovoSorb® BTM has also been used successfully in surgeries to help heal large wounds, suggesting it is effective without causing many issues. Researchers are studying both treatments to ensure they are safe and effective for people with Hidradenitis Suppurativa, a condition that causes painful skin lumps. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the treatments for hidradenitis suppurativa because they offer innovative approaches compared to standard options like antibiotics, steroids, and surgical interventions. NovaSorb® BTM is unique because it uses a synthetic polyurethane matrix that encourages the body’s own healing processes, potentially leading to quicker recovery and reduced scarring. On the other hand, the Human Cadaveric Allograft provides a natural tissue replacement, which may integrate better with the patient's own tissue, offering a promising alternative to more invasive surgeries. Both treatments aim to improve healing and patient outcomes in ways that current methods might not fully address.

What evidence suggests that this trial's treatments could be effective for Hidradenitis Suppurativa?

Research has shown that NovoSorb® BTM, a special type of wound dressing, effectively treats complex wounds, including those from hidradenitis suppurativa. Studies indicate it helps cover and heal deep wounds with low infection rates and few side effects. In previous cases, patients experienced positive results using NovoSorb BTM for severe skin conditions. In this trial, participants will receive either NovoSorb BTM or a Human Cadaveric Allograft. Traditionally, human donor skin has been used for wound coverage, but detailed information about its effectiveness for hidradenitis suppurativa is limited. Overall, NovoSorb BTM appears promising due to its successful use in treating similar wounds. ^{4 6 7 8 9}

Who Is on the Research Team?

Zaheed Hassan, MD

Principal Investigator

JOSEPH M STILL RESEARCH FOUNDATION

Are You a Good Fit for This Trial?

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

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

I have severe HS needing major surgery.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Human Cadaveric Allograft
• NovaSorb® BTM

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.

How Is the Trial Designed?

Group I: NovoSorb® BTM Experimental Treatment 1 Intervention

Group II: Human Cadaver Allograft Active Control 1 Intervention

Human Cadaveric Allograft is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Human Cadaveric Allograft for:

• Burns
• Wound care
• Hidradenitis suppurativa excisions

Approved in European Union as Human Cadaveric Allograft for:

• Burns
• Wound care
• Skin reconstruction

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+

Published Research Related to This Trial

NovoSorb Biodegradable Temporising Matrix (BTM) is an effective reconstructive option for various complex skin defects, including those from burns and infections, as it allows for a two-stage reconstruction process that can lead to successful skin grafting.

Despite complications like infection and non-adherence, BTM showed a good tolerance to these issues, often allowing the reconstruction process to continue as planned after vascularization, which is indicated by a red-pink color and capillary refill.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A consecutive case series of defects reconstructed using NovoSorbⓇ Biodegradable Temporising Matrix: Initial experience and early results. Solanki, NS., York, B., Gao, Y., et al.[2020]

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]

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]

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 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]

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]

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]

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 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]

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 study of 30 patients with chronic axillary hidradenitis suppurativa, both split thickness skin grafts (STSG) and fasciocutaneous flaps were found to be effective for reconstructive surgery, with no recurrence of the condition observed at one-year follow-up.

Patients reported high satisfaction with both the aesthetic outcomes and functional recovery, as all had normal ranges of motion and no significant pain at the graft or flap sites during follow-ups at one month, six months, and one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Split Thickness Skin Grafts and Flaps in Bilateral Chronic Axillary Hidradenitis Suppurativa. Afsharfard, A., Khodaparast, MB., Zarrintan, S., et al.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2468912222000153

Single staged treatment of a complex full thickness ... Debridement of hidradenitis suppurativa and coverage using NovoSorb BTM for soft tissue coverage can yield great results. Abstract. Treatment of full skin ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05477225

Study Details | NCT05477225 | A Randomized, Controlled ... A Randomized, Controlled Trial Comparing the Use of a Biodegradable Temporizing Matrix to Cadaver Skin in the Reconstruction of Hidradenitis Suppurativa ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S246891222400066X

A systematic review of the Novosorb® Biodegradable ... NovoSorb® BTM is effective in treating complex wounds with low infection rates. Minimal adverse events were reported with NovoSorb® BTM use.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37053370/

Novosorb® Biodegradable Temporising Matrix (BTM) and ... BTM has been used to reconstruct deep dermal and full-thickness burns, necrotising fasciitis, and free flap donor sites in the early phase.

5. mdpi.com mdpi.com/2073-4360/17/19/2563

Synthetic Electrospun Fiber Matrix in the Management of ... ... hidradenitis suppurativa: Outcomes of 590 consecutive patients. ... Novosorb® Biodegradable Temporizing Matrix in reconstruction of complex wounds.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05477225

Study Details | NCT05477225 | A Randomized, Controlled ... This will be a prospective, interventional, single-center, randomized, controlled, comparative study comparing a total of 10 patients treated with BTM and SOC ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681525001329

A review of NovoSorb Biodegradable Temporising Matrix ... We present a retrospective, cross-sectional review of 12 patients who underwent surgical reconstruction with NovoSorb® Biodegradable Temporising Matrix ...

8. polynovo.com polynovo.com/wp-content/uploads/2411-NovoSorb-BTM-Clinical-publication-Nov-2024.pdf

Clinical Publication Update In this case, NovoSorb BTM was used successfully for reconstruction of the sizeable defect by optimising graft take and enhancing aesthetic outcome. This has ...

9. polynovo.com polynovo.com/wp-content/uploads/2023/05/Digital-NovoSorb-BTM-Clinical-Compendium.pdf

Clinical Compendium For this innovation and subsequent clinical outcomes recognized using NovoSorb BTM, PolyNovo® has been the recipient of several awards, the FDA Breakthrough ...