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

NCT05389410 | Recruiting DMC

• 1 other identifier: RL1 786
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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). 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.

Conditions

Surgical Wound

Keywords

Revision hip and revision knee surgery

Outcome Measures

Primary Outcomes (3)

• 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%

  Within the first 2 weeks post-surgery

• 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.

  For the study duration, up to 6 weeks post-surgery.

• 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).

  For the study duration, up to 6 weeks post-surgery.

Secondary Outcomes (1)

• Wound appearance documented by photographs from before the dressing is applied in theatre to 6 weeks post-surgery follow up visit.

  For the study duration, up to 6 weeks post-surgery.

Study Arms (2)

Revision Hip surgery

EXPERIMENTAL

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

Device: PICO 7; Device: PICO 14

Revision knee surgery

ACTIVE COMPARATOR

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

Device: PICO 7; Device: PICO 14

Interventions

PICO 7 DEVICE

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

Also known as: 7 day NPWT

Revision Hip surgery; Revision knee surgery

PICO 14 DEVICE

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

Also known as: 14 day NPWT

Revision Hip surgery; Revision knee surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead

Study Sites (1)

Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, SY10 7AG, United Kingdom

RECRUITING

Related Publications (10)

• 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.

  PMID: 24741386 RESULT

• 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.

  PMID: 28370637 RESULT

• 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.

  PMID: 28642657 RESULT

• 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.

  PMID: 30464709 RESULT

• 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.

  PMID: 30545653 RESULT

• 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.

  PMID: 27496913 RESULT

• Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.

  PMID: 1100130 RESULT

• 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.

  PMID: 23832671 RESULT

• The ASA's Statement on p-values: Context, Process, and Purpose

  RESULT

• 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.

  PMID: 17695343 RESULT

MeSH Terms

Conditions

Surgical Wound

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Sudheer L Karlakki

  The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Steen, BSc. (Hons)

CONTACT

01691404210; julie.steen@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 25, 2022
• Study Start: February 14, 2024
• Primary Completion: February 14, 2026
• Study Completion (Estimated): February 14, 2027
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)