Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05389410

PICO 7 vs PICO 14 in Revision Hip and Revision Knee Surgery.

Led by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust · Updated on 2024-03-25

164

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a single-site trial, and it has been designed to compare a revision hip cohort with a revision knee cohort. All consecutive eligible patients, under the care of participating Co-Investigator Orthopaedic Surgeons, are approached for recruitment into the study. Eligible patients wishing to participate must require either revision hip or revision knee surgery and consent to be randomised to either NPWT PICO dressing for 7-day therapy (PICO 7) or NPWT PICO 14-day therapy (PICO 14). 82 Revision Hips and 82 Revision Knee participants, with 41\* of each cohort randomised to either a 7-day or a 14-day NPWT dressing treatment duration period. The 7-day cohort will be treated with PICO7 dressings and pumps, and the 14-day cohort will be treated with PICO14 dressings. \*Randomisation will be stratified, so it will continue until there are at least 41 participants in each cohort.

CONDITIONS

Official Title

PICO 7 vs PICO 14 in Revision Hip and Revision Knee Surgery.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must be over the age of 18 years.
  • Undergoing aseptic revision hip or aseptic revision knee surgery (single stage revision).
  • Willing and able to attend all required study visits at the outpatient department.
  • Able to follow study instructions.
Not Eligible

You will not qualify if you...

  • Revision surgeries for infection affecting wound healing or discharge.
  • History of poor compliance with medical treatment.
  • Allergies or contraindications to NPWT PICO dressing components such as silicone adhesives, polyurethane films, acrylic adhesives, polyethylene fabrics, or polyacrylates.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, United Kingdom, SY10 7AG

Actively Recruiting

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Research Team

J

Julie Steen, BSc. (Hons)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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