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

March 21, 2024 updated by: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Shropshire
      • Oswestry, Shropshire, United Kingdom, SY10 7AG
        • Recruiting
        • Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Revision Hip surgery
Participants will be randomised to PICO 7 or PICO 14 intervention.
Device: PICO 7
Participant will receive 7 days of NPWT following revision hip or revision knee surgery.
Other Names:
  • 7 day NPWT
Device: PICO 14
Participant will receive 14 days of NPWT following revision hip or revision knee surgery.
Other Names:
  • 14 day NPWT
Active Comparator: Revision knee surgery
Participants will be randomised to PICO 7 or PICO 14 intervention.
Device: PICO 7
Participant will receive 7 days of NPWT following revision hip or revision knee surgery.
Other Names:
  • 7 day NPWT
Device: PICO 14
Participant will receive 14 days of NPWT following revision hip or revision knee surgery.
Other Names:
  • 14 day NPWT

What is the study measuring?

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).
Time Frame: Within the first 2 weeks post-surgery

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).
Time Frame: For the study duration, up to 6 weeks post-surgery.

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.
Time Frame: For the study duration, up to 6 weeks post-surgery.
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.
Time Frame: For the study duration, up to 6 weeks post-surgery.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Collaborators

Smith & Nephew, Inc.

Investigators

  • Principal Investigator: Sudheer L Karlakki, The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2024

Primary Completion (Estimated)

February 14, 2026

Study Completion (Estimated)

February 14, 2027

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RL1 786

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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