Hidradenitis SuppurativaHIDRANCT04325607
Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa
A study testing Excision of HS followed by NPWTi and Excision of HS followed by NPWT in people with Hidradenitis Suppurativa, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Excision of HS followed by NPWTi and Excision of HS followed by NPWT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2019to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Free NHS Foundation Trust Hospital London
London, NW3 2QG
About this study
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa
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.
Read the 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 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Excision of HS followed by NPWTi, Excision of HS followed by NPWT
- Keywords
- Hidradenitis Suppurativa, Negative pressure wound therapy with instillation, Negative pressure wound therapy
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excision of HS followed by NPWTiProcedure or surgery
Also called VAC VERAFLO™ Therapy
The NPWTi that will be used in this study will be the V.A.C. VERAFLO™ Therapy (KCI)
Excision of HS followed by NPWTProcedure or surgery
Also called VAC Therapy
The NPWT that will be used in this study will be the V.A.C.® Therapy(KCI)
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy with instillation | Experimental | Patients in the treatment group will be initiated on VeraFlo instillation (NPWTi) therapy upon excision of HS Receives: Procedure: Excision of HS followed by NPWTi |
| Negative Pressure Wound Therapy | Active comparator | Patient in the control group will be initiated on VAC therapy (NPWT) upon excision of HS Receives: Procedure: Excision of HS followed by NPWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
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
Measured: 2 weeks
Secondary outcomes (5)
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.
Measured: 1 week
Percentage of graft take at week 1 and week 4
Percentage of skin graft survival at week 1 and week 4
Measured: 4 weeks
Number of patients with recurrence of HS at 3 and 6 months
Number of patients with recurrence of disease at 3 and 6 months
Measured: 6 months
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
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Sep 2019
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Why it stopped: Recruitment was affected by the previous COVID pandemic and patient referral pathway was interrupted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- KCI Europe Holding B.V.
- Responsible party
- Sponsor
- Investigators
- Ash Mosahebi, Study director, Royal Free NHS Foundation Trust London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325607
- Sponsor's protocol ID
- 247179
- Acronym
- HIDRA
- Status last verified
- Dec 2023
- First submitted
- 16 Jan 2020
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Efficacy of Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT04325607
- Acronym / sponsor ID
- HIDRA / 247179
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, Negative pressure wound therapy with instillation, Negative pressure wound therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was affected by the previous COVID pandemic and patient referral pathway was interrupted
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- KCI Europe Holding B.V.
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy with instillation | Experimental | Procedure: Excision of HS followed by NPWTiPatients in the treatment group will be initiated on VeraFlo instillation (NPWTi) therapy upon excision of HS |
| Negative Pressure Wound Therapy | Active comparator | Procedure: Excision of HS followed by NPWTPatient in the control group will be initiated on VAC therapy (NPWT) upon excision of HS |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excision of HS followed by NPWTiAlso: VAC VERAFLO™ TherapyThe NPWTi that will be used in this study will be the V.A.C. VERAFLO™ Therapy (KCI) | Procedure or surgery | Negative Pressure Wound Therapy with instillation |
| Excision of HS followed by NPWTAlso: VAC TherapyThe NPWT that will be used in this study will be the V.A.C.® Therapy(KCI) | Procedure or surgery | Negative Pressure Wound Therapy |
Primary outcome
The mean days to wound coverage with split skin graft (SSG) after excision of HS
Time frame: 2 weeks
Mean days to wound coverage with split skin graft (SSG) after excision of HS in each treatment arm
The difference in bacterial count on the wound after NPWTi against NPWT
Time frame: 2 weeks
Reduction in the number of colony-forming unit (CFU) at each dressing change analysed using tissue culture of wound bed biopsies
5 secondary outcomes
Proportion of wounds covered with SSG at 1 week post excision
Time frame: 1 week
Percentage of graft take at week 1 and week 4
Time frame: 4 weeks
Number of patients with recurrence of HS at 3 and 6 months
Time frame: 6 months
Number of patients with improved Dermatology Life Quality Index (DLQI)
Time frame: 6 months
The difference in cost between both treatments
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Recruitment was affected by the previous COVID pandemic and patient referral pathway was interrupted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ash Mosahebi study director
Royal Free NHS Foundation Trust London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excision of HS followed by NPWTi and Excision of HS followed by NPWT in people with Hidradenitis Suppurativa, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was affected by the previous COVID pandemic and patient referral pathway was interrupted). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean days to wound coverage with split skin graft (SSG) after excision of HS (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.