Status:
TERMINATED
Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa
Lead Sponsor:
Royal Free Hospital NHS Foundation Trust
Collaborating Sponsors:
KCI Europe Holding B.V.
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The current surgical management for severe Hidradenitis suppurativa (HS) involves wide excision of affected skin, resulting in a large soft tissue defect. The soft tissue defect will then be managed w...
Detailed Description
HS is a recurring chronic skin disease of the hair follicle that usually presents with painful and inflamed lesions in the sweat gland-bearing areas of the body. The lesions often progress to become c...
Eligibility Criteria
Inclusion
- Male and female
- Age 18-90 at the time of consent
- Clinical diagnosis of axillary hidradenitis suppurativa
- Unilateral axillary hidradenitis suppurativa (if bilateral disease, only one side will be included into study).
- Hidradenitis suppurativa with multiple sinuses which are not able to close directly
- Not on antibiotics for 6 weeks
- Patient understands and is willing to participate
Exclusion
- Hidradenitis suppurativa with isolated sinus for direct closure
- Patient with ongoing chemotherapy or radiotherapy
- Patient with active cancer
- Uncontrolled Diabetes Mellitus, as measured by an HbA1c \> 10%.
- BMI over 35
- Active smoker
- Presence of one or more medical conditions, including renal, hepatic, hematologic, active auto-immune or immune diseases that, would make the subject an inappropriate candidate for this wound healing study
- Patient not fit for surgery (ASA classification \> 4)
- Patients not able to consent for procedure in English
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04325607
Start Date
September 1 2019
End Date
October 1 2023
Last Update
December 19 2023
Active Locations (1)
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1
Royal Free NHS Foundation Trust Hospital London
London, United Kingdom, NW3 2QG