RECRUITING

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

Description

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).

Study Overview

Study Details

Study overview

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).

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

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

Condition
Hidradenitis Suppurativa
Intervention / Treatment

-

Contacts and Locations

Augusta

Joseph M. Still Research Foundation, Augusta, Georgia, United States, 30909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Joseph M. Still Research Foundation, Inc.,

Zaheed Hassan, MD, PRINCIPAL_INVESTIGATOR, JOSEPH M STILL RESEARCH FOUNDATION

Study Record Dates

2025-07-30