NCT05477225

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Joseph M. Still Research Foundation, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-07-30
• Completion: 2025-07-30
• First posted: 2022-07-28
• Last updated: 2023-09-28

Locations

1 site across 1 country: United States