A Randomized, Controlled Trial Comparing the Use of a Biodegradable Temporizing Matrix to Cadaver Skin in the Reconstruction of Hidradenitis Suppurativa Excisions
Status unconfirmed · Phase 4
Conditions studied: Hidradenitis Suppurativa
In brief
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).
Key facts
- Study ID
- NCT05477225
- Run by
- Joseph M. Still Research Foundation, Inc.
- People needed
- 10
- Starts
- 2022-10-01
- Expected to finish
- 2025-07-30
- Last updated by the study team
- 2023-09-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Is ≥18 years of age
- Has presented to the Joseph M. Still Burn Center at Doctors Hospital Augusta or Advanced Wound Clinic for treatment of HS
- Diagnosed with chronic Hidradenitis Suppurativa that requires a wide surgical excision in the following anatomical areas (e.g. groin, axillae, buttocks or inframammary folds)
- Diagnosed with Hurley Stage 3 HS that requires wide surgical excision
- Patient can still have micro-abscesses
- Subject or their legally authorized representative is able to provide informed consent
- Males or non-pregnant females. Females of childbearing potential (FCBP) must have a negative urine or serum pregnancy test at Baseline
- Willing to comply with all study procedures and expects to be available for the duration of the study
- Negative Pressure Wound Therapy is needed to stabilize and support study graft
You may not qualify if…
- Has a cardiac risk (NYHA Classification III)
- 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,
- Has coagulopathy that in the opinion of the investigator, would place subject at an increased risk for bleeding.
- Has a known hypersensitivity to polyurethane
- Anticipates a level of non-compliance
- Significant risk factors for poor wound healing
- BMI > 40
Where it is running
- Joseph M. Still Research Foundation — Augusta, Georgia, United States (enrolling)
Full record on ClinicalTrials.gov
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