At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- PICO 7 (device), PICO 14 (device)
- How long the study runs
- Study runs about 36 months (dates as stated)
- About the drug or intervention
- PICO 7 — device: Participant will receive 7 days of NPWT following revision hip or revision knee surgery. · PICO 14 — device: Participant will receive 14 days of NPWT following revision hip or revision knee surgery.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 164
- Started
- 2024-02-14
- Last checked
- 2024-03
Plain English Summary
What is this study?
- • Testing a new treatment for surgical wound
- • NA - 164 participants
- • This is a single-site trial, and it has been designed to compare a revision hip cohort with a revision knee cohort
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with surgical wound
Where?
- • Oswestry - Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This 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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ study visits to be seen by the research team at the Outpatients department at RJAH
What the study is looking for
- ✓Subjects must be over the age of 18 years.
- ✓Participants undergoing aseptic revision hip or aseptic revision knee surgery procedure (a single stage revision...
- ✓Participants must be willing and be able to make all the required study visits to be seen by the research team at...
- ✓Participants must be able to follow instructions.
Who cannot take part
- ✗Revisions for infection, where the nature of the infection has a significant influence on the wound healing,...
- ✗Subjects with a history of poor compliance with medical treatment.
See the full criteria
Where Is This Study? (1 UK site)
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry SY10 7AG, United Kingdom
How to Get in Touch
Julie Steen, BSc. (Hons)
Sponsor contactCONTACT