Comparing a new biodegradable matrix to cadaver skin for treating Hidradenitis Suppurativa wounds

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

This study is testing if a new biodegradable material works better than cadaver skin for healing wounds from Hidradenitis Suppurativa in patients after surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Joseph M. Still Research Foundation, Inc. (Academic / other)
• Locations: 1 site (Augusta, Georgia)
• Trial ID: NCT05477225 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of a biodegradable temporizing matrix (NovoSorb® BTM) against standard of care (cadaver skin) in the reconstruction of wounds caused by Hidradenitis Suppurativa. A total of 10 patients will be enrolled and randomly assigned to receive either treatment after undergoing surgical excision of affected areas. The study will follow standard surgical procedures and assess wound healing outcomes through photographs and clinical evaluations. The trial is conducted at the Joseph M. Still Burn Center in Augusta, Georgia.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with Hurley Stage 3 Hidradenitis Suppurativa requiring surgical excision.

Not a fit: Patients with significant cardiac risks or active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and safer option for wound healing in patients with Hidradenitis Suppurativa.

How similar studies have performed: While this approach is novel in the context of Hidradenitis Suppurativa, similar studies using biodegradable matrices have shown promise in other wound healing applications.

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

Where this trial is running

Augusta, Georgia

• Joseph M. Still Research Foundation — Augusta, Georgia, United States (Recruiting)

Study contacts

• Principal investigator: Zaheed Hassan, MD — Joseph M Still Research Foundation
• Study coordinator: Joan Wilson, MSN, MHA, RN

Conditions Hidradenitis Suppurativa; NovoSorb® BTM