Hidradenitis SuppurativaPhase 4NCT05477225
A Randomized, Controlled Trial Comparing the Use of a Biodegradable Temporizing Matrix to Cadaver Skin in the Reconstruction of Hidradenitis Suppurativa Excisions
A Phase 4 study testing NovoSorb® BTM and Human Cadaveric Allograft in people with Hidradenitis Suppurativa, run by Joseph M. Still Research Foundation, Inc. at 1 site in United States.
Trial summary
This will be a prospective, interventional, single-center, randomized, controlled, comparative study comparing a total of 10 patients treated with BTM and SOC in wounds diagnosed with Hidradenitis suppurativa (5 in each group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- NovoSorb® BTM and Human Cadaveric Allograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 30 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is ≥18 years of age
- Has presented to the Joseph M. Still Burn Center at Doctors Hospital Augusta or Advanced Wound Clinic for treatment of HS
- Diagnosed with chronic Hidradenitis Suppurativa that requires a wide surgical excision in the following anatomical areas (e.g. groin, axillae, buttocks or inframammary folds)
- Diagnosed with Hurley Stage 3 HS that requires wide surgical excision
- Patient can still have micro-abscesses
- Subject or their legally authorized representative is able to provide informed consent
Show all 9Show fewer
- Males or non-pregnant females. Females of childbearing potential (FCBP) must have a negative urine or serum pregnancy test at Baseline
- Willing to comply with all study procedures and expects to be available for the duration of the study
- Negative Pressure Wound Therapy is needed to stabilize and support study graft
Who cannot join
- Has a cardiac risk (NYHA Classification III)
- Has active diagnosis of any autoimmune process, cancer, or organ failure that in the opinion of the investigator would prevent the subject from successfully participating in the study,
- Has coagulopathy that in the opinion of the investigator, would place subject at an increased risk for bleeding.
- Has a known hypersensitivity to polyurethane
- Anticipates a level of non-compliance
- Significant risk factors for poor wound healing
- BMI > 40
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Joseph M. Still Research Foundation
Augusta, Georgia, 30909
Joan Wilson, 706-364-2966, joan.wilson@jmsresearchfoundation.org
Bounthavy Homsombath, M.D
About this study
This will be a prospective, interventional, single-center, randomized, controlled, comparative study comparing a total of 10 patients treated with BTM and SOC in wounds diagnosed with Hidradenitis suppurativa (5 in each group).
Read the detailed description
The goal of enrollment will be up to 10 subjects, which is based on feasibility and access to suitable patients during the enrollment period.
Subjects will be consented prior to any study procedure being performed. Surgical planning, approach and procedures will follow the standard of care (SOC) already established by the JMS Burn Center at Doctors Hospital Augusta surgical team. After an aggressive, wide excision, and thorough debridement and cleansing of the affected lesions will be performed. Photos of the prepared wound bed will be taken prior to study product placement of both wounds. To prepare the wound bed, study eligible patients will receive either the BTM or SOC to each of their wounds. BTM will be placed on the surgically prepared wound bed and fixated with sutures or staples, according to manufacturer's recommendations, local clinical practice, and the clinical judgement of the investigator. SOC will be placed according to manufacturer's recommendations, local clinical practice, and the clinical judgement of the investigator. Photos of the wound bed with the BTM/SOC study product in place will be taken. A mesh-type, non-adherent dressing (ConformantTM, Smith \& Nephew or something similar) will be placed over the study product to prevent shear and friction. An antimicrobial dressing to help prevent infection (such as ActicoatTM, Smith \& Nephew or SilverlonTM, Cura Surgical) may be used but must be used over both wounds. Adequate padding with gauze will be placed over the top of the non-adherent, or antimicrobial dressing, KerlixTM rolls will be used as the outer dressing and Ace wrap or Sepro net dressing may be used as needed to hold all in place. Negative Pressure Wound Therapy will also be used in conjunction with the BTM or SOC, (at the discretion and clinical judgment of the investigator) to help manage exudate and improve the contact of the BTM and SOC to the wound bed.
Follow up will be in the wound clinic as per normal SOC on Day 7,14,21, etc., (+/-3 days), until assessment of the study site determines that the wound is ready for grafting. Subject will be processed for the autografting operative procedure as per normal SOC. Once in the OR, the research study team will capture pertinent surgical data related to the skin graft: level of excision, meshing ratio, type of fixation, type of cover dressing. Photos will be taken post debridement and after product placement. Post-op, the patient will continue to be seen in the clinic on a weekly basis and autograft take, and presence of shear, friction or infection will be documented.
Long term follow up will take place at 3,6, and 12 months. Study sites will be assessed for scar quality using the POSAS scale. ROM will be assessed for subjects if the wounds were in the axillae region. AE/SAE surveillance will be continued throughout the study and at all study visits.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- NovoSorb® BTM, Human Cadaveric Allograft
- Keywords
- NovoSorb® BTM
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoSorb® BTMDevice
a biodegradable polyurethane porous matrix adhered to a transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative moisture loss during integration of the matrix.
Human Cadaveric AllograftDevice
The donated human tissue (Allograft) used in this study are from Maxxeus Medical, Kettering, OH . Tissue grafts are recovered from deceased human donors. All tissue is recovered, processed, stored and distributed for use in accordance with the standards of the American Association of Tissue Banks (AATB). Tissue is manufactured in a clean room environment, following rigorous quality assurance standards. The procedures executed to manufacture this graft including recovery, donor screening, testing, processing, packaging, labeling, storage, and distribution were performed in compliance with all applicable local, state, and federal regulations, including the U.S. Food and Drug Administration (FDA) regulations published at 21 CFR Part 1271, and the current edition of the American Association of Tissue Banks Standards for Tissue Banking.
The current sizes that are available for this study: 103 sq cm., 154 sq cm and 232 sq. cm
| Study group | Role | What they receive |
|---|---|---|
| NovoSorb® BTM | Experimental | Not described Receives: Device: NovoSorb® BTM |
| Human Cadaver Allograft | Active comparator | Not described Receives: Device: Human Cadaveric Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days between initial excision and split-thickness skin grafting
To compare the mean days to wound coverage with split skin graft (STSG) after excision of HS between wounds treated with either BTM or SOC
Measured: 6 weeks
Secondary outcomes (11)
Percentage of autograft take
To compare percentage autograft take between wounds treated with BTM or SOC
Measured: 6 weeks
Incidence rates of Infection
To compare incidence and severity of infection between wounds treated with BTM or SOC
Measured: 6 weeks
Success rate of resolving infections
To assess the success rate of resolving local infections with retention of the investigational device in place (BTM or SOC)
Measured: 6 weeks
Scar Assessment using objective/subjective assessment tool
To compare the scar appearance/quality over time of wounds treated with BTM or SOC using the using the Patient and Observer Scar Assessment Scale (POSAS)
Measured: 12 months
Measuring range of motion in axillae subjects
To compare range of motion (axillae subjects only) in wounds that were treated with BTM or SOC
Measured: 12 months
Total cost of the treatment
The difference in cost between both treatments (Data on the total cost of treatment between both treatment groups will be compared. The total cost will combine the cost of procedures, cost of devices, any additional devices or procedures cost and cost of clinic follow ups)
Measured: 12 months
Total number of pieces used
To compare the number of pieces (sheets) of dermal replacement devices (BTM or SOC) used to treat the designated study sites.
Measured: 6 weeks
Number of additional surgical procedures
To compare the number and type of any additional surgical procedures to treat the designated study sites (e.g. replacement of lost graft/removal for infection)
Measured: 6 weeks
Total costs of rehabilitation for axillae subjects
To compare any rehabilitation costs required for scar contracture (on axillae subjects only)
Measured: 12 months
Recurrence rates of hidradenitis suppurativa
To compare any reoccurrence of HS in the same anatomical locations
Measured: 12 months
Number of re-operations needed for disease reoccurrence
To compare any requirement for re-operation for disease reoccurrence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Oct 2022
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph M. Still Research Foundation, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- PolyNovo Biomaterials Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Zaheed Hassan, MD, Principal investigator, JOSEPH M STILL RESEARCH FOUNDATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477225
- Sponsor's protocol ID
- JMSRF-BTM-HDN-P01
- Status last verified
- Sep 2023
- First submitted
- 18 Jul 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Comparing the Use of a Biodegradable Temporizing Matrix to Cadaver Skin in the Reconstruction of Hidradenitis Suppurativa Excisions
- ClinicalTrials.gov ID
- NCT05477225
- Acronym / sponsor ID
- JMSRF-BTM-HDN-P01
- Conditions
- Hidradenitis Suppurativa
- Keywords
- NovoSorb® BTM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Joseph M. Still Research Foundation, Inc.University, hospital or other
- Collaborators
- PolyNovo Biomaterials Pty Ltd.
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a prospective, interventional, single-center, randomized, controlled, comparative study comparing a total of 10 patients treated with BTM and SOC in wounds diagnosed with Hidradenitis suppurativa (5 in each group).
Detailed description
The goal of enrollment will be up to 10 subjects, which is based on feasibility and access to suitable patients during the enrollment period.
Subjects will be consented prior to any study procedure being performed. Surgical planning, approach and procedures will follow the standard of care (SOC) already established by the JMS Burn Center at Doctors Hospital Augusta surgical team. After an aggressive, wide excision, and thorough debridement and cleansing of the affected lesions will be performed. Photos of the prepared wound bed will be taken prior to study product placement of both wounds. To prepare the wound bed, study eligible patients will receive either the BTM or SOC to each of their wounds. BTM will be placed on the surgically prepared wound bed and fixated with sutures or staples, according to manufacturer's recommendations, local clinical practice, and the clinical judgement of the investigator. SOC will be placed according to manufacturer's recommendations, local clinical practice, and the clinical judgement of the investigator. Photos of the wound bed with the BTM/SOC study product in place will be taken. A mesh-type, non-adherent dressing (ConformantTM, Smith \& Nephew or something similar) will be placed over the study product to prevent shear and friction. An antimicrobial dressing to help prevent infection (such as ActicoatTM, Smith \& Nephew or SilverlonTM, Cura Surgical) may be used but must be used over both wounds. Adequate padding with gauze will be placed over the top of the non-adherent, or antimicrobial dressing, KerlixTM rolls will be used as the outer dressing and Ace wrap or Sepro net dressing may be used as needed to hold all in place. Negative Pressure Wound Therapy will also be used in conjunction with the BTM or SOC, (at the discretion and clinical judgment of the investigator) to help manage exudate and improve the contact of the BTM and SOC to the wound bed.
Follow up will be in the wound clinic as per normal SOC on Day 7,14,21, etc., (+/-3 days), until assessment of the study site determines that the wound is ready for grafting. Subject will be processed for the autografting operative procedure as per normal SOC. Once in the OR, the research study team will capture pertinent surgical data related to the skin graft: level of excision, meshing ratio, type of fixation, type of cover dressing. Photos will be taken post debridement and after product placement. Post-op, the patient will continue to be seen in the clinic on a weekly basis and autograft take, and presence of shear, friction or infection will be documented.
Long term follow up will take place at 3,6, and 12 months. Study sites will be assessed for scar quality using the POSAS scale. ROM will be assessed for subjects if the wounds were in the axillae region. AE/SAE surveillance will be continued throughout the study and at all study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NovoSorb® BTM | Experimental | Device: NovoSorb® BTM |
| Human Cadaver Allograft | Active comparator | Device: Human Cadaveric Allograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is ≥18 years of age
- Has presented to the Joseph M. Still Burn Center at Doctors Hospital Augusta or Advanced Wound Clinic for treatment of HS
- Diagnosed with chronic Hidradenitis Suppurativa that requires a wide surgical excision in the following anatomical areas (e.g. groin, axillae, buttocks or inframammary folds)
- Diagnosed with Hurley Stage 3 HS that requires wide surgical excision
- Patient can still have micro-abscesses
Key exclusion criteria (7 listed)
- Has a cardiac risk (NYHA Classification III)
- Has active diagnosis of any autoimmune process, cancer, or organ failure that in the opinion of the investigator would prevent the subject from successfully participating in the study,
- Has coagulopathy that in the opinion of the investigator, would place subject at an increased risk for bleeding.
- Has a known hypersensitivity to polyurethane
- Anticipates a level of non-compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovoSorb® BTMa biodegradable polyurethane porous matrix adhered to a transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative moisture loss during integration of the matrix. | Device | NovoSorb® BTM |
| Human Cadaveric AllograftThe donated human tissue (Allograft) used in this study are from Maxxeus Medical, Kettering, OH . Tissue grafts are recovered from deceased human donors. All tissue is recovered, processed, stored and distributed for use in accordance with the standards of the American Association of Tissue Banks (AATB). Tissue is manufactured in a clean room environment, following rigorous quality assurance standards. The procedures executed to manufacture this graft including recovery, donor screening, testing, processing, packaging, labeling, storage, and distribution were performed in compliance with all applicable local, state, and federal regulations, including the U.S. Food and Drug Administration (FDA) regulations published at 21 CFR Part 1271, and the current edition of the American Association of Tissue Banks Standards for Tissue Banking. The current sizes that are available for this study: 103 sq cm., 154 sq cm and 232 sq. cm | Device | Human Cadaver Allograft |
Primary outcome
Number of days between initial excision and split-thickness skin grafting
Time frame: 6 weeks
To compare the mean days to wound coverage with split skin graft (STSG) after excision of HS between wounds treated with either BTM or SOC
11 secondary outcomes
Percentage of autograft take
Time frame: 6 weeks
Incidence rates of Infection
Time frame: 6 weeks
Success rate of resolving infections
Time frame: 6 weeks
Scar Assessment using objective/subjective assessment tool
Time frame: 12 months
Measuring range of motion in axillae subjects
Time frame: 12 months
Total cost of the treatment
Time frame: 12 months
Total number of pieces used
Time frame: 6 weeks
Number of additional surgical procedures
Time frame: 6 weeks
Total costs of rehabilitation for axillae subjects
Time frame: 12 months
Recurrence rates of hidradenitis suppurativa
Time frame: 12 months
Number of re-operations needed for disease reoccurrence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Related trials for Hidradenitis Suppurativa
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaheed Hassan, MD principal investigator
JOSEPH M STILL RESEARCH FOUNDATION
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NovoSorb® BTM and Human Cadaveric Allograft in people with Hidradenitis Suppurativa, run by Joseph M. Still Research Foundation, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joan Wilson, MSN, MHA, RN (7063642966, joan.wilson@jmsresearchfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days between initial excision and split-thickness skin grafting (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.