NCT05389410 PICO 7 vs PICO 14 in Revision Hip and Revision Knee Surgery.
| NCT ID | NCT05389410 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust |
| Condition | Surgical Wound |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2024-02-14 |
| Primary Completion | 2026-02-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 164 participants in total. It began in 2024-02-14 with a primary completion date of 2026-02-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Sudheer L Karlakki
PRINCIPAL INVESTIGATOR
The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust
Frequently Asked Questions
Who can join the NCT05389410 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgical Wound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05389410 currently recruiting?
Yes, NCT05389410 is actively recruiting participants. Contact the research team at julie.steen@nhs.net for enrollment information.
Where is the NCT05389410 trial being conducted?
This trial is being conducted at Oswestry, United Kingdom.
Who is sponsoring the NCT05389410 clinical trial?
NCT05389410 is sponsored by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust. The principal investigator is Sudheer L Karlakki at The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust. The trial plans to enroll 164 participants.