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

NCT05477225 | Unknown Phase 4

• 1 other identifier: JMSRF-BTM-HDN-P01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Hidradenitis Suppurativa

Keywords

NovoSorb® BTM

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Secondary Outcomes (11)

• Percentage of autograft take

  6 weeks

• Incidence rates of Infection

  6 weeks

• Success rate of resolving infections

  6 weeks

• Scar Assessment using objective/subjective assessment tool

  12 months

• Measuring range of motion in axillae subjects

  12 months

Study Arms (2)

NovoSorb® BTM

EXPERIMENTAL

Device: NovoSorb® BTM

Human Cadaver Allograft

ACTIVE COMPARATOR

Device: Human Cadaveric Allograft

Interventions

NovoSorb® BTM DEVICE

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.

NovoSorb® BTM

Human Cadaveric Allograft DEVICE

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

Human Cadaver Allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph M. Still Research Foundation, Inc.: lead
• PolyNovo Biomaterials Pty Ltd.: collaborator

Study Sites (1)

Joseph M. Still Research Foundation

Augusta, Georgia, 30909, United States

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Zaheed Hassan, MD

  JOSEPH M STILL RESEARCH FOUNDATION

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan Wilson, MSN, MHA, RN

CONTACT

7063642966; joan.wilson@jmsresearchfoundation.org

Austin Price, BS

CONTACT

7063642966; austin.price@jmsresearchfoundation.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 28, 2022
• Study Start: October 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

US (1)