What side effects are associated with this type of intervention?

Common treatments for Hidradenitis Suppurativa (HS) include surgical interventions, antibiotics, hormonal therapies, and biologics. Surgical treatments, like the use of Biodegradable Temporizing Matrix (BTM), can lead to complications such as infection, scarring, and delayed wound healing. Antibiotics may cause gastrointestinal upset, antibiotic resistance, and allergic reactions. Hormonal therapies, such as spironolactone, can result in menstrual irregularities, breast tenderness, and hyperkalemia. Biologics, including TNF-alpha inhibitors, may increase the risk of infections, injection site reactions, and potential exacerbation of other conditions like inflammatory bowel disease.

What prior FDA approvals exist?

The FDA has approved several treatments for Hidradenitis Suppurativa, primarily focusing on biologic therapies. Adalimumab (Humira) is the first and only FDA-approved biologic for moderate to severe HS, targeting TNF-alpha to reduce inflammation. While there is limited information on FDA-approved treatments specifically involving tissue regeneration similar to the Biodegradable Temporizing Matrix (BTM), current research and trials are exploring innovative approaches to improve wound healing and tissue repair in HS patients.

What other types of research exist?

One promising alternative to BTM for Hidradenitis Suppurativa patients is the use of ABCB5+ mesenchymal stem cells (MSCs), referred to as allo-APZ2-EB. This treatment has shown reductions in disease activity, scarring, itch, and pain in a phase 1/2 trial and has been granted orphan drug designation by the US FDA and the European Medicines Agency. Another potential alternative is the use of recombinant collagen type VII for protein replacement therapy, which has shown promise in preclinical studies for wound healing and tissue regeneration.

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BTM vs Human Cadaveric Allograft for Hidradenitis Suppurativa

Phase 4

Recruiting

Led By Zaheed Hassan, MD

Research Sponsored by Joseph M. Still Research Foundation, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with Hurley Stage 3 HS that requires wide surgical excision

Is ≥18 years of age

Must not have

Has a cardiac risk (NYHA Classification III)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

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.

Who is the study for?

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).

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions to the materials used like polyurethane found in BTM (e.g., redness or irritation), infection risk from grafts, and general complications associated with wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe HS needing major surgery.

Select...

I am 18 years old or older.

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

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I am a man or a woman not currently pregnant. If capable of becoming pregnant, I have a negative pregnancy test.

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I need a special wound therapy to help my graft heal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have moderate heart disease that affects my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of days between initial excision and split-thickness skin grafting

Secondary study objectives

Incidence rates of Infection

Measuring range of motion in axillae subjects

Number of additional surgical procedures

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NovoSorb® BTMExperimental Treatment1 Intervention

Group II: Human Cadaver AllograftActive Control1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Biodegradable Temporizing Matrix (BTM) provides a scaffold for new tissue growth, which is essential for effective wound healing in Hidradenitis Suppurativa (HS) patients. This mechanism is particularly important because HS involves chronic, painful abscesses and sinus tracts that require robust wound management. By facilitating new tissue formation, BTM can improve healing outcomes and reduce lesion recurrence. Other common treatments for HS include antibiotics to manage infection, anti-inflammatory medications to reduce inflammation, and surgical interventions to remove affected tissue. These treatments collectively aim to control symptoms, prevent complications, and enhance the quality of life for HS patients.