Recruiting

Biodegradable Temporizing Matrix vs. Cadaver Skin

Sponsor:

Joseph M. Still Research Foundation, Inc.

Code:

NCT05477225

Conditions

Hidradenitis Suppurativa

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NovoSorb® BTM

Human Cadaveric Allograft

Study Details

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

Study ID

NCT05477225

Start date

Oct 1, 2022

Status verified date

Sep, 2023

Completion date

Jul 30, 2025

Anticipated

Primary completion date

Jul 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NovoSorb® BTM

active comparator: Human Cadaver Allograft

Interventions

NovoSorb® BTM

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 Allograft

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

Primary outcome measure

  • Number of days between initial excision and split-thickness skin grafting [ Time Frame: 6 weeks ]

Central Contacts and Locations

Locations

Joseph M. Still Research Foundation

Recruiting

Augusta, Georgia, United States, 30909

Contacts

Principal Investigator:

Bounthavy Homsombath, M.D

More Information

Sponsor

Joseph M. Still Research Foundation, Inc.

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Keywords

  • NovoSorb® BTM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Joseph M. Still Research Foundation, Inc. on 2023-09-28.