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NCT Number: NCT05389410

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

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.

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Key information

Conditions

Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location status: Recruiting

Location contact

Julie Steen

CONTACT

[email protected]

01691404210

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PICO 7

Device

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

Other names: 7 day NPWT

PICO 14

Device

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

Other names: 14 day NPWT

Primary outcomes

  1. 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%

  2. 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.

  3. 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).

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Steen, BSc. (Hons)

CONTACT

[email protected]

01691404210

Sponsors and collaborators

Lead sponsor

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Other Gov

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 25, 2022
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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