RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-10-01

Study Completion:2025-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05477225

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Joan Wilson, MSN, MHA, RN

CONTACT

7063642966

joan.wilson@jmsresearchfoundation.org

Austin Price, BS

CONTACT

7063642966

austin.price@jmsresearchfoundation.org

Principal Investigator

Zaheed Hassan, MD

PRINCIPAL_INVESTIGATOR

JOSEPH M STILL RESEARCH FOUNDATION

Study Locations (Sites)

Joseph M. Still Research Foundation

Augusta, Georgia, 30909

United States

Collaborators and Investigators

Sponsor: Joseph M. Still Research Foundation, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01

Study Completion Date2025-07-30

Study Record Updates

Study Start Date2022-10-01

Study Completion Date2025-07-30

Terms related to this study

Keywords Provided by Researchers

NovoSorb® BTM

Additional Relevant MeSH Terms

Hidradenitis Suppurativa