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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will compare two treatments for Hidradenitis suppurativa: BTM and SOC, to see which works best.
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).Check my eligibility
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.See study design
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 belowSelect...
I have severe HS needing major surgery.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of days between initial excision and split-thickness skin grafting
Secondary outcome measures
Incidence rates of Infection
Measuring range of motion in axillae subjects
Number of additional surgical procedures
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NovoSorb® BTMExperimental Treatment1 Intervention
Group II: Human Cadaver AllograftActive Control1 Intervention
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Who is running the clinical trial?
Joseph M. Still Research Foundation, Inc.Lead Sponsor
8 Previous Clinical Trials
348 Total Patients Enrolled
PolyNovo Biomaterials Pty Ltd.Industry Sponsor
3 Previous Clinical Trials
190 Total Patients Enrolled
Zaheed Hassan, MDPrincipal InvestigatorJOSEPH M STILL RESEARCH FOUNDATION
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any autoimmune diseases, other cancers, or organ failures that would stop me from being in the study.I have severe HS needing major surgery.I have chronic Hidradenitis Suppurativa needing major surgery in areas like groin or underarms.I am 18 years old or older.I have conditions that could slow down my wound healing.You have a body mass index (BMI) higher than 40.You have a condition that could make you more likely to bleed, according to the study doctor's opinion.I am a man or a woman not currently pregnant. If capable of becoming pregnant, I have a negative pregnancy test.I need a special wound therapy to help my graft heal.You are allergic to polyurethane.I have moderate heart disease that affects my daily activities.I may have small abscesses.
Research Study Groups:
This trial has the following groups:- Group 1: Human Cadaver Allograft
- Group 2: NovoSorb® BTM
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted approval to NovaSorb® BTM?
"Due to its Phase 4 status, NovaSorb® BTM has been granted a safety rating of 3 by our team here at Power. This demonstrates that the treatment is approved and market-ready."
Answered by AI
What is the highest capacity of participants in this research?
"Affirmative. The information available on clinicaltrials.gov alludes to this research's active recruitment of participants which began October 1st 2022 and was last updated March 8th2023. Thus far, 10 patients have been enrolled from one site only."
Answered by AI
Is this research currently seeking to enroll new participants?
"According to records on clinicaltrials.gov, this scientific experiment is currently searching for volunteers. It was initially shared online on October 1st 2022 and the details were most recently updated in March 8th 2023."
Answered by AI
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