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
About this trial
This is an interventional treatment trial for Surgical Wound focused on measuring Revision hip and revision knee surgery
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.
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
NCT ID
NCT05389410
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.
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
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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
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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.
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Citation
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Results Reference
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PICO 7 vs PICO 14 in Revision Hip and Revision Knee Surgery.
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