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Negative Pressure Wound Therapy With Instillation for Treatment of Hidradenitis Suppurativa

NCT04325607 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-12-19

No results posted yet for this study

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

Interventions

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)

PROCEDURE

Excision of HS followed by NPWT

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

Sponsors & Collaborators

  • KCI Europe Holding B.V.

    collaborator INDUSTRY

  • Royal Free Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Ash Mosahebi · Royal Free NHS Foundation Trust London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2023-10-01
Completion
2023-10-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04325607 on ClinicalTrials.gov