NCT05389410

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

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Although the efficacy of these dressings is well established in promoting wound healing, the duration of application particularly in revision surgeries, where the surgery has been carried out though old scar tissues is however undetermined at present. The few published studies regarding this do show a benefit, however, they do not address the potential issues surrounding late wound breakdown and the duration of the NPWT on the wound 4,5. Therefore a proposed randomised study to evaluate whether one-week of negative pressure wound therapy is sufficient or whether a two-week therapy duration is warranted. This will be done by randomising a minimum of 82 patients who are scheduled for revision hip surgery and 82 patients who are scheduled for revision knee surgery into either a "control group" or a "study group". The 'control group' cohort will receive a NPWT PICO 7 dressing and pump for a period of week, followed by a hydrocolloid dressing or other standard dressing applied thereafter. The 'study group' cohort will receive a NPWT PICO 14 dressing and pump for a period of 2 weeks, with a dressing change at one week. The pump will be paused during the dressing change, restarting it again once the new dressing has been applied and sealed for another week's NPWT.

Conditions

• Surgical Wound

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-14
• Primary completion: 2026-02-14
• Completion: 2027-02-14
• First posted: 2022-05-25
• Last updated: 2024-03-25

Locations

1 site across 1 country: United Kingdom