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).

Conditions

Hidradenitis Suppurativa

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