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RECRUITING
NCT05389410
NA

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

Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

View on ClinicalTrials.gov

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.

Official title: Comparison of Surgical Wound Healing and Complications Following Revision Hip and Knee Replacements, Utilising a 7-day Versus 14-day Negative Pressure Wound Therapy (NPWT) Dressing. A Randomised Controlled Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

164

Start Date

2024-02-14

Completion Date

2027-02-14

Last Updated

2024-03-25

Healthy Volunteers

No

Conditions

Interventions

DEVICE

PICO 7

Participant will receive 7 days of NPWT following revision hip or revision knee surgery.

DEVICE

PICO 14

Participant will receive 14 days of NPWT following revision hip or revision knee surgery.

Locations (1)

Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, United Kingdom