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

Primary Purpose

Surgical Wound

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PICO 7
PICO 14
Sponsored by
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound focused on measuring Revision hip and revision knee surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Revision Hip surgery

    Revision knee surgery

    Arm Description

    Participants will be randomised to PICO 7 or PICO 14 intervention.

    Participants will be randomised to PICO 7 or PICO 14 intervention.

    Outcomes

    Primary Outcome Measures

    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%
    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.
    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).

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    May 16, 2022
    Last Updated
    May 20, 2022
    Sponsor
    Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
    Collaborators
    Smith & Nephew, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05389410
    Brief Title
    PICO 7 vs PICO 14 in Revision Hip and Revision Knee Surgery.
    Official 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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
    Collaborators
    Smith & Nephew, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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). 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Wound
    Keywords
    Revision hip and revision knee surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Revision Hip surgery
    Arm Type
    Experimental
    Arm Description
    Participants will be randomised to PICO 7 or PICO 14 intervention.
    Arm Title
    Revision knee surgery
    Arm Type
    Active Comparator
    Arm Description
    Participants will be randomised to PICO 7 or PICO 14 intervention.
    Intervention Type
    Device
    Intervention Name(s)
    PICO 7
    Other Intervention Name(s)
    7 day NPWT
    Intervention Description
    Participant will receive 7 days of NPWT following revision hip or revision knee surgery.
    Intervention Type
    Device
    Intervention Name(s)
    PICO 14
    Other Intervention Name(s)
    14 day NPWT
    Intervention Description
    Participant will receive 14 days of NPWT following revision hip or revision knee surgery.
    Primary Outcome Measure Information:
    Title
    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).
    Description
    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%
    Time Frame
    Within the first 2 weeks post-surgery
    Title
    Late wound dehiscence or wound discharge (discharge from the wound once the PICO dressing has been discontinued).
    Description
    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.
    Time Frame
    For the study duration, up to 6 weeks post-surgery.
    Title
    Observance of the formation of wound complications, specifically superficial wound infection, and deep wound infection.
    Description
    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).
    Time Frame
    For the study duration, up to 6 weeks post-surgery.
    Secondary Outcome Measure Information:
    Title
    Wound appearance documented by photographs from before the dressing is applied in theatre to 6 weeks post-surgery follow up visit.
    Description
    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.
    Time Frame
    For the study duration, up to 6 weeks post-surgery.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julie Steen, BSc. (Hons)
    Phone
    01691404210
    Email
    julie.steen@nhs.net

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24741386
    Citation
    Malmsjo M, Huddleston E, Martin R. Biological effects of a disposable, canisterless negative pressure wound therapy system. Eplasty. 2014 Apr 2;14:e15. eCollection 2014.
    Results Reference
    result
    PubMed Identifier
    28370637
    Citation
    Nherera LM, Trueman P, Karlakki SL. Cost-effectiveness analysis of single-use negative pressure wound therapy dressings (sNPWT) to reduce surgical site complications (SSC) in routine primary hip and knee replacements. Wound Repair Regen. 2017 May;25(3):474-482. doi: 10.1111/wrr.12530. Epub 2017 May 3.
    Results Reference
    result
    PubMed Identifier
    28642657
    Citation
    Helito CP, Bueno DK, Giglio PN, Bonadio MB, Pecora JR, Demange MK. NEGATIVE-PRESSURE WOUND THERAPY IN THE TREATMENT OF COMPLEX INJURIES AFTER TOTAL KNEE ARTHROPLASTY. Acta Ortop Bras. 2017 Mar-Apr;25(2):85-88. doi: 10.1590/1413-785220172502169053.
    Results Reference
    result
    PubMed Identifier
    30464709
    Citation
    Miyahara HS, Serzedello FR, Ejnisman L, Lima ALLM, Vicente JRN, Helito CP. INCISIONAL NEGATIVE-PRESSURE WOUND THERAPY IN REVISION TOTAL HIP ARTHROPLASTY DUE TO INFECTION. Acta Ortop Bras. 2018;26(5):300-304. doi: 10.1590/1413-785220182605196038.
    Results Reference
    result
    PubMed Identifier
    30545653
    Citation
    Newman JM, Siqueira MBP, Klika AK, Molloy RM, Barsoum WK, Higuera CA. Use of Closed Incisional Negative Pressure Wound Therapy After Revision Total Hip and Knee Arthroplasty in Patients at High Risk for Infection: A Prospective, Randomized Clinical Trial. J Arthroplasty. 2019 Mar;34(3):554-559.e1. doi: 10.1016/j.arth.2018.11.017. Epub 2018 Nov 17.
    Results Reference
    result
    PubMed Identifier
    27496913
    Citation
    Karlakki SL, Hamad AK, Whittall C, Graham NM, Banerjee RD, Kuiper JH. Incisional negative pressure wound therapy dressings (iNPWTd) in routine primary hip and knee arthroplasties: A randomised controlled trial. Bone Joint Res. 2016 Aug;5(8):328-37. doi: 10.1302/2046-3758.58.BJR-2016-0022.R1.
    Results Reference
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    PubMed Identifier
    1100130
    Citation
    Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
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    PubMed Identifier
    23832671
    Citation
    Barbachano Y, Coad DS. Inference following designs which adjust for imbalances in prognostic factors. Clin Trials. 2013 Aug;10(4):540-51. doi: 10.1177/1740774513493367. Epub 2013 Jul 5.
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    Citation
    The ASA's Statement on p-values: Context, Process, and Purpose
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    PubMed Identifier
    17695343
    Citation
    Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
    Results Reference
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    PICO 7 vs PICO 14 in Revision Hip and Revision Knee Surgery.

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