PICO 7 vs PICO 14 in Revision Hip and Revision Knee Surgery.
NCT ID: NCT05389410
Last Updated: 2024-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
164 participants
INTERVENTIONAL
2024-02-14
2027-02-14
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Revision Hip surgery
Participants will be randomised to PICO 7 or PICO 14 intervention.
PICO 7
Participant will receive 7 days of NPWT following revision hip or revision knee surgery.
PICO 14
Participant will receive 14 days of NPWT following revision hip or revision knee surgery.
Revision knee surgery
Participants will be randomised to PICO 7 or PICO 14 intervention.
PICO 7
Participant will receive 7 days of NPWT following revision hip or revision knee surgery.
PICO 14
Participant will receive 14 days of NPWT following revision hip or revision knee surgery.
Interventions
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PICO 7
Participant will receive 7 days of NPWT following revision hip or revision knee surgery.
PICO 14
Participant will receive 14 days of NPWT following revision hip or revision knee surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
OTHER_GOV
Responsible Party
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Principal Investigators
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Sudheer L Karlakki
Role: PRINCIPAL_INVESTIGATOR
The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust
Locations
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Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
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.
The ASA's Statement on p-values: Context, Process, and Purpose
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.
Other Identifiers
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RL1 786
Identifier Type: -
Identifier Source: org_study_id
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