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

NCT05389410 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2024-03-25

No results posted yet for this study

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.

Conditions

  • Surgical Wound

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.

Sponsors & Collaborators

  • Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Sudheer L Karlakki · The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2026-02-14
Completion
2027-02-14

Countries

  • United Kingdom

Study Locations

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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 NCT05389410 on ClinicalTrials.gov