Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa

NCT04325607 | Terminated DMC

• 1 other identifier: 247179
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; Negative pressure wound therapy with instillation; Negative pressure wound therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Proportion of wounds covered with SSG at 1 week post excision

  1 week

• Percentage of graft take at week 1 and week 4

  4 weeks

• Number of patients with recurrence of HS at 3 and 6 months

  6 months

• Number of patients with improved Dermatology Life Quality Index (DLQI)

  6 months

• The difference in cost between both treatments

  6 months

Study Arms (2)

Negative Pressure Wound Therapy with instillation

EXPERIMENTAL

Patients in the treatment group will be initiated on VeraFlo instillation (NPWTi) therapy upon excision of HS

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

Procedure: Excision of HS followed by NPWT

Interventions

Excision of HS followed by NPWTi PROCEDURE

The NPWTi that will be used in this study will be the V.A.C. VERAFLO™ Therapy (KCI)

Also known as: VAC VERAFLO™ Therapy

Negative Pressure Wound Therapy with instillation

Excision of HS followed by NPWT PROCEDURE

The NPWT that will be used in this study will be the V.A.C.® Therapy(KCI)

Also known as: VAC Therapy

Negative Pressure Wound Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead
• KCI Europe Holding B.V.: collaborator

Study Sites (1)

Royal Free NHS Foundation Trust Hospital London

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Ash Mosahebi

  Royal Free NHS Foundation Trust London

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: March 27, 2020
• Study Start: September 1, 2019
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)