Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04325607
Other study ID # 247179
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date October 1, 2023

Study information

Verified date December 2023
Source Royal Free Hospital NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 with Negative Pressure Wound Therapy (NPWT) to promote healthy granulation tissue formation for wound coverage with Split skin graft (SSG). This long interval between excision and reconstruction could result in long in-patient stay, increased risk of hospital acquired infection and reduced patients' quality of life. The investigators wish to evaluate the use of Negative Pressure Wound Therapy with instillation (NPWTi), which has potential to allow early wound coverage with SSG, as an alternative to the current standard of care. The investigators hypothesise that NPWTi reduces bacterial load on the wound and allows early wound coverage hence improves patient satisfaction and reduces cost and length of hospital stay.


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 chronic with pus discharge and scar formation resulting in significant disability. Current surgical management for severe HS involves surgical removal of all involved hair bearing skin resulting in large areas of soft tissue loss which requires reconstruction. The wound is reconstructed by performing skin grafting, known as SSG, whereby a healthy layer of skin is transferred to the area of tissue loss. SSG enables rapid wound healing and has low risk of recurrence of HS. Skin grafting is often done a few weeks after excision of HS (delayed setting) to ensure higher success rate due to the infected nature of HS. During the interval between surgical removal of areas with HS and skin grafting, the wound is managed with a suction dressing known as the Negative Pressure Wound Therapy (NPWT) to promote formation of healthy wound bed. NPWT is a form of vacuum dressing which applies continuous suction pressure on the wound to remove fluids and bacteria from the wound bed. The NPWT is highly successful in managing such wounds, however a novel and innovative improvement to this technology with an irrigation system, the Negative Pressure Wound Therapy with instillation (NPWTi), holds promise to enhance production of healthy wound bed and further reducing bacteria and infectious materials from the wound, enabling earlier wound coverage with SSG. The NPWTi involves irrigating and soaking the wound with fluid, followed by removal of the fluid via application of suction pressure at timed, regular intervals. The goal of the instillation therapy is to enable early application of SSG as wound irrigation has long been appreciated as beneficial for cleaning contaminated wounds. The investigators wish to evaluate the NPWTi as an alternative to NPWT for current surgical management strategy of severe HS. The investigators wish to determine if NPWTi allows early wound coverage with SSG which improves patient satisfaction and reduces length of hospital stay. This research will further our knowledge about the human wound healing process and it may help improve treatment for future patients. The investigators plan to study up to 44 patients in total.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: 1. Male and female 2. Age 18-90 at the time of consent 3. Clinical diagnosis of axillary hidradenitis suppurativa 4. Unilateral axillary hidradenitis suppurativa (if bilateral disease, only one side will be included into study). 5. Hidradenitis suppurativa with multiple sinuses which are not able to close directly 6. Not on antibiotics for 6 weeks 7. Patient understands and is willing to participate Exclusion Criteria: 1. Hidradenitis suppurativa with isolated sinus for direct closure 2. Patient with ongoing chemotherapy or radiotherapy 3. Patient with active cancer 4. Uncontrolled Diabetes Mellitus, as measured by an HbA1c > 10%. 5. BMI over 35 6. Active smoker 7. 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 8. Patient not fit for surgery (ASA classification > 4) 9. Patients not able to consent for procedure in English

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Excision of HS followed by NPWTi
The NPWTi that will be used in this study will be the V.A.C. VERAFLO™ Therapy (KCI)
Excision of HS followed by NPWT
The NPWT that will be used in this study will be the V.A.C.® Therapy(KCI)

Locations

Country Name City State
United Kingdom Royal Free NHS Foundation Trust Hospital London London

Sponsors (2)

Lead Sponsor Collaborator
Royal Free Hospital NHS Foundation Trust KCI Europe Holding B.V.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The mean days to wound coverage with split skin graft (SSG) after excision of HS Mean days to wound coverage with split skin graft (SSG) after excision of HS in each treatment arm 2 weeks
Primary The difference in bacterial count on the wound after NPWTi against NPWT Reduction in the number of colony-forming unit (CFU) at each dressing change analysed using tissue culture of wound bed biopsies 2 weeks
Secondary Proportion of wounds covered with SSG at 1 week post excision The proportion of wounds (in percentage) covered with split skin graft at 1 week post excision. 1 week
Secondary Percentage of graft take at week 1 and week 4 Percentage of skin graft survival at week 1 and week 4 4 weeks
Secondary Number of patients with recurrence of HS at 3 and 6 months Number of patients with recurrence of disease at 3 and 6 months 6 months
Secondary Number of patients with improved Dermatology Life Quality Index (DLQI) Dermatology Life Quality Index (DLQI) will be used to measure the improvement in quality of life. Comparison will be made between DLQI during pre operative period and 6 months post operative 6 months
Secondary The difference in cost between both treatments Data on the total cost of treatment between both treatment groups will be compared. The total cost will combine the cost of procedures, cost of devices, cost of inpatient stay and cost of clinic follow ups. 6 months
See also
  Status Clinical Trial Phase
Completed NCT02904902 - Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa Phase 3
Completed NCT03628924 - A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS) Phase 2
Not yet recruiting NCT05531747 - Replicative Stress in Hair Follicle Stem Cells and Pathogeny of Hidradenitis Suppurativa N/A
Recruiting NCT06028230 - A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Phase 2
Completed NCT03275870 - Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa Phase 1/Phase 2
Completed NCT03248531 - A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa. Phase 2
Withdrawn NCT04100083 - Spironolactone for Hidradenitis Suppurativa Phase 4
Completed NCT00329823 - Etanercept in Hidradenitis Suppurativa Phase 2
Recruiting NCT05710393 - Hidradenitis - an Analysis of Genetic Traits and Linkages in Families
Completed NCT04019041 - A Study to Evaluate the Efficacy, Safety and Tolerability of Bermekimab in Patients With Hidradenitis Suppurativa Phase 2
Completed NCT05286567 - A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa. Phase 1
Withdrawn NCT03929835 - Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa Phase 2
Terminated NCT03238469 - Microwave Ablation in Mild Axillary Hidradenitis Suppurativa N/A
Completed NCT04449354 - HidraWear AX HS Study N/A
Recruiting NCT06123429 - Mindfulness in Hidradenitis Suppurativa N/A
Recruiting NCT05934825 - Clinical Trial to Evaluate Safety and Efficiency of Mesenchymal Stem Cell in Patients With Hidradenitis Suppurativa Phase 1/Phase 2
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT06046729 - A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Phase 2
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2
Completed NCT01516749 - Anakinra as a Treatment for Hydradenitis Suppurativa Phase 2