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Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa (HIDRA)

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ClinicalTrials.gov Identifier: NCT04325607
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : March 27, 2020
Sponsor:
Collaborator:
KCI Europe Holding B.V.
Information provided by (Responsible Party):
Royal Free Hospital NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE January 16, 2020
First Posted Date  ICMJE March 27, 2020
Last Update Posted Date March 27, 2020
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • Proportion of wounds covered with SSG at 1 week post excision [ Time Frame: 1 week ]
    The proportion of wounds (in percentage) covered with split skin graft at 1 week post excision.
  • Percentage of graft take at week 1 and week 4 [ Time Frame: 4 weeks ]
    Percentage of skin graft survival at week 1 and week 4
  • Number of patients with recurrence of HS at 3 and 6 months [ Time Frame: 6 months ]
    Number of patients with recurrence of disease at 3 and 6 months
  • Number of patients with improved Dermatology Life Quality Index (DLQI) [ Time Frame: 6 months ]
    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
  • The difference in cost between both treatments [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa
Official Title  ICMJE A Randomized Controlled Trial to Evaluate the Efficacy of Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa
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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE
  • 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)
    Other Name: VAC VERAFLO™ Therapy
  • Procedure: Excision of HS followed by NPWT
    The NPWT that will be used in this study will be the V.A.C.® Therapy(KCI)
    Other Name: VAC Therapy
Study Arms  ICMJE
  • Experimental: Negative Pressure Wound Therapy with instillation
    Patients in the treatment group will be initiated on VeraFlo instillation (NPWTi) therapy upon excision of HS
    Intervention: Procedure: Excision of HS followed by NPWTi
  • Active Comparator: Negative Pressure Wound Therapy
    Patient in the control group will be initiated on VAC therapy (NPWT) upon excision of HS
    Intervention: Procedure: Excision of HS followed by NPWT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2020)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Muholan Kanapathy, PhD 020 7794 0500 m.kanapathy@ucl.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04325607
Other Study ID Numbers  ICMJE 247179
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Royal Free Hospital NHS Foundation Trust
Study Sponsor  ICMJE Royal Free Hospital NHS Foundation Trust
Collaborators  ICMJE KCI Europe Holding B.V.
Investigators  ICMJE
Study Director: Ash Mosahebi Royal Free NHS Foundation Trust London
PRS Account Royal Free Hospital NHS Foundation Trust
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP