Instillation therapy for hidradenitis suppurativa (HIDRA)
Research type
Research Study
Full title
A randomised controlled trial to evaluate the efficacy of negative pressure wound therapy with instillation for treatment of hidradenitis suppurativa
IRAS ID
247179
Contact name
Afshin Mosahebi
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust Hospital
Eudract number
2017-002891-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Hidradenitis suppurativa (HS) is a distressing, recurring chronic inflammatory skin disease of the hair follicle that usually presents with painful and inflamed lesions in the apocrine gland-bearing areas of the body. The lesions often progress to become chronic with purulent discharge, sinus formation and scarring resulting in significant disability.
Current surgical management for severe HS involves radical excision of all involved hair bearing skin resulting in large soft tissue defect which requires reconstruction. Split skin graft (SSG) is the reconstruction option of choice as it is associated with low recurrence and rapid wound healing. Skin grafting is often done in a delayed setting (few weeks after excision of HS) due to the infected nature of HS. During this interim, Negative Pressure Wound Therapy (NPWT) is used to stimulate the wound bed to promote formation of healthy granulation tissue.
The use of Negative Pressure Wound Therapy with instillation (NPWTi) holds promise as an adjunctive therapy to enhance production of granulation tissue and reduce bacterial load, enabling earlier wound coverage with SSG. In addition to the conventional NPWT, the NPWTi involves irrigating and soaking the wound, followed by removal of the fluid via application of negative pressure at timed, regular intervals, while the foam dressing remains in place. The goal of the instillation therapy is to condition the wound for early closure after radical tissue debridement as wound irrigation has long been appreciated as beneficial for cleaning contaminated wounds. The addition of instilled fluid lowers the wound fluid viscosity, which in turn facilitates more efficient removal of exudate and infectious material.
We wish to evaluate the NPWTi as an alternative to NPWT for current surgical management strategy of severe HS. We 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.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0353
Date of REC Opinion
22 Feb 2019
REC opinion
Further Information Favourable Opinion