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

RecruitingNAAges 18 Years - anyAllRobert Jones and Agnes Hunt Orthopaedic and Distr…
NCT05389410 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subjects must be over the age of 18 years. * Participants undergoing aseptic revision hip or aseptic revision knee surgery procedure (a single stage revision procedure). * Participants must be willing and be able to make all the required study visits to be seen by the research team at the Outpatients department at RJAH. * Participants must be able to follow instructions. Exclusion Criteria: * Revisions for infection, where the nature of the infection has a significant influence on the wound healing, discharge, and length of stay. * Subjects with a history of poor compliance with medical treatment. * Subjects with contraindications (as per the PICO Instructions for use) or hypersensitivity to the use of the NPWT PICO dressing product or its components e.g.: silicone adhesives, polyurethane films, acrylic adhesives, polyethylene fabrics and super- absorbent powders (polyacrylates) contained within the dressing.
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What it tests

  • PICO 7
  • PICO 14
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Where

1 site
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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