Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Julie Steen, BSc. (Hons) 01691404210
julie.steen@nhs.net


Study Location:

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Be Part of Research - Trial Details - PICO 7 vs PICO 14 in Revision Hip and Revision Knee Surgery.

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

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Surgical Wound


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2024 Feb 2026

Publications

"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."; "24741386"; "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."; "28370637"; "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."; "28642657"; "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."; "30464709"; "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."; "30545653"; "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."; "27496913"; "Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15."; "1100130"; "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."; "23832671"; "The ASA's Statement on p-values: Context, Process, and Purpose"; null; "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."; "17695343"

INTERVENTIONAL

Intervention Type : DEVICE
Intervention Description : Participant will receive 7 days of NPWT following revision hip or revision knee surgery.

Intervention Arm Group : Revision Hip surgery;Revision knee surgery;

Intervention Type : DEVICE
Intervention Description : Participant will receive 14 days of NPWT following revision hip or revision knee surgery.

Intervention Arm Group : Revision Hip surgery;Revision knee surgery;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
    Oswestry
    Shropshire
    SY10 7AG

Julie Steen, BSc. (Hons) 01691404210
julie.steen@nhs.net



The study is sponsored by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust




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Read full details for Trial ID: NCT05389410
Last updated 21 March 2024

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