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

Study Overview
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Brief Summary
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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). 50 Revision Hips and 50 Revision Knee participants, with 25* 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 25 participants in each cohort.

Detailed Description
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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 50 patients who are scheduled for revision hip surgery and 50 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.

Official Title
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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.

Conditions
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Surgical Wound

Intervention / Treatment
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* Device: PICO 7
* Device: PICO 14


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revision Hip surgery<br>Participants will be randomised to PICO 7 or PICO 14 intervention. | Device: PICO 7<br>* Participant will receive 7 days of NPWT following revision hip or revision knee surgery.<br>* Other names: 7 day NPWT;Device: PICO 14<br>* Participant will receive 14 days of NPWT following revision hip or revision knee surgery.<br>* Other names: 14 day NPWT;|
| Active Comparator: Revision knee surgery<br>Participants will be randomised to PICO 7 or PICO 14 intervention. | Device: PICO 7<br>* Participant will receive 7 days of NPWT following revision hip or revision knee surgery.<br>* Other names: 7 day NPWT;Device: PICO 14<br>* Participant will receive 14 days of NPWT following revision hip or revision knee surgery.<br>* Other names: 14 day NPWT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The extent of wound exudate graded 1-4. This is measured by the extent of staining on the dressing at 1-week post-surgery (both study and control groups) and 2 weeks post-surgery (study group only). | The extent of wound exudate graded 1-4 (measured by the extent of staining on the dressing) at 1 week and 2 weeks at follow up appointments. Grading of wound exudate levels and the amount of exudate on the coverage of the dressing: Grade 0 None No staining Grade 1 Light < 25% Grade 2 Moderate 25% to 50% Grade 3 Heavy 50% to 75% Grade 4 Overt > 75% | Within the first 2 weeks post-surgery | 
| Late wound dehiscence or wound discharge (discharge from the wound once the PICO dressing has been discontinued). | If there is any wound discharge after the PICO has been discontinued as per the protocol. The duration of wound discharge (any patients experiencing persistent discharge beyond 48 hrs will be brought back to clinic and dealt appropriately as per the Consultants preferred management methods). If there is any wound dehiscence or breakdown (patients will be brought back to clinic and again, dealt appropriately as per consultants preferred wound management method). The management of persistent wound discharge may require hospitalisation, wound washout or continued and/or prolonged use of a PICO dressing. These are all part of the standard of care at RJAH, but their use does vary slightly, depending on individual preferences of the supervising Surgeon. | For the study duration, up to 6 weeks post-surgery. | 
| Observance of the formation of wound complications, specifically superficial wound infection, and deep wound infection. | The number of wound complications, specifically concerning superficial wound infections and deep wound infections. The patient will be monitored at 1 week (clinic visit), 2 week (clinic visit), 3 week (phone call), and 6 weeks (clinic visit). | For the study duration, up to 6 weeks post-surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound appearance documented by photographs from before the dressing is applied in theatre to 6 weeks post-surgery follow up visit. | The appearance of the wound at the 1-week clinic visit, where the dressing is changed or PICO therapy discontinued, depending on the treatment arm that the patient has been randomised to, the 2-week clinic visit, where the study cohort of patients will have their second dressing removed and at the 6-week clinic visit. The evidence of the wound appearance at these time points will be documented through photographs. | For the study duration, up to 6 weeks post-surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revision hip and revision knee surgery