BTM vs Human Cadaveric Allograft for Hidradenitis Suppurativa
What You Need to Know Before You Apply
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.
Is NovoSorb BTM safe for use in humans?
How does the treatment with NovoSorb BTM differ from other treatments for hidradenitis suppurativa?
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.89101112
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for wound healing, infection, and graft take, with assessments continuing until the wound is ready for grafting.
Long-term Follow-up
Long-term follow-up to assess scar quality, range of motion, and recurrence of hidradenitis suppurativa.
What Are the Treatments Tested in This Trial?
Interventions
- Human Cadaveric Allograft
- NovaSorb® BTM
Human Cadaveric Allograft is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joseph M. Still Research Foundation, Inc.
Lead Sponsor
PolyNovo Biomaterials Pty Ltd.
Industry Sponsor