A Randomized, Controlled Trial Comparing the Use of a Biodegradable Temporizing Matrix to Cadaver Skin in the Reconstruction of Hidradenitis Suppurativa Excisions

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Brief Title

A Randomized, Controlled Trial Comparing the Use of a Biodegradable Temporizing Matrix to Cadaver Skin in the Reconstruction of Hidradenitis Suppurativa Excisions

Official Title

A Randomized, Controlled Trial Comparing the Use of a Biodegradable Temporizing Matrix to Cadaver Skin in the Reconstruction of Hidradenitis Suppurativa Excisions

Brief 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).
    

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Percentage of autograft take

Condition

Hidradenitis Suppurativa

Intervention

NovaSorb® BTM

Study Arms / Comparison Groups

 NovaSorb® BTM
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

September 1, 2022

Completion Date

March 1, 2024

Primary Completion Date

March 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Is ≥18 years of age

          2. Has presented to the Joseph M. Still Burn Center at Doctors Hospital Augusta or
             Advanced Wound Clinic for treatment of HS

          3. Diagnosed with chronic Hidradenitis Suppurativa that requires a wide surgical excision
             in the following anatomical areas (e.g. groin, axillae, buttocks or inframammary
             folds)

          4. Diagnosed with Hurley Stage 3 HS that requires wide surgical excision

          5. Patient can still have micro-abscesses

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

          7. Males or non-pregnant females. Females of childbearing potential (FCBP) must have a
             negative urine or serum pregnancy test at Baseline

          8. Willing to comply with all study procedures and expects to be available for the
             duration of the study

          9. Negative Pressure Wound Therapy is needed to stabilize and support study graft

        Exclusion Criteria:

          1. Has a cardiac risk (NYHA Classification III)

          2. 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,

          3. Has coagulopathy that in the opinion of the investigator, would place subject at an
             increased risk for bleeding.

          4. Has a known hypersensitivity to polyurethane

          5. Anticipates a level of non-compliance

          6. Significant risk factors for poor wound healing

          7. BMI > 40
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Zaheed Hassan, MD, 7063642966, [email protected]



Administrative Informations


NCT ID

NCT05477225

Organization ID

JMSRF-BTM-HDN-P01


Responsible Party

Sponsor

Study Sponsor

Joseph M. Still Research Foundation, Inc.

Collaborators

 PolyNovo Biomaterials Pty Ltd.

Study Sponsor

Zaheed Hassan, MD, Principal Investigator, JOSEPH M STILL RESEARCH FOUNDATION


Verification Date

July 2022