Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000004965p
Ethics application status
Not yet submitted
Date submitted
10/09/2019
Date registered
8/01/2020
Date last updated
8/01/2020
Date data sharing statement initially provided
8/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A non randomised pragmatic trial for the early detection and prevention of surgical wound complications using an advanced hydropolymer wound dressing and smartphone technology; the EDISON study.
Scientific title
A non randomised pragmatic trial for the early detection and prevention of surgical wound complications using an advanced hydroplymer wound dressing and smartphone techonology; the EDISON study.
Secondary ID [1] 299240 0
NIL
Universal Trial Number (UTN)
U1111-1239-9961
Trial acronym
EDISON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
wound healing 314371 0
obesity 314372 0
surgical site infection 314374 0
Condition category
Condition code
Skin 312706 312706 0 0
Dermatological conditions
Infection 312707 312707 0 0
Studies of infection and infectious agents
Skin 312708 312708 0 0
Other skin conditions
Diet and Nutrition 312831 312831 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participant will have a standard surgical dressing covering their surgical incision after surgery. The dressing is a transparent hydroplymer wound dressing, currently used in clinical practice. The dressing is transparent and allows for complete visibility of wound healing progress whilst leaving the dressing intact. The dressing wear time is 7 days. The patient will have the ability to capture digital images of their incisional wound via their smartphone, while at home, and transmit them to the study clinician for review and early identification of potential wound complications. Photos will be sent daily to the study clinician for review. For monitoring and compliance the participant will be in contact with study personnel every second day to assist with queries or troubleshooting.
Intervention code [1] 315611 0
Early detection / Screening
Intervention code [2] 315612 0
Prevention
Comparator / control treatment
This is a non randomised pragmatic trial that does not utilise a comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321347 0
1. Primary clinical outcome: Occurrence of surgical wound complications: surgical site infection as assessed by the study clinician and per the Centres for Disease Control definition (1) and /or SWD (Y/N) as classified using the Sandy/WUWHS SWD Grading System (2). Photos will be utilised to determine this outcome along side further clinical consultation direct with the patient in a clinic.

(1)Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infection control and hospital epidemiology. 1992;13(10):606-8.
(2)World Union of Wound Healing Societies (WUWHS) Consensus Document. Surgical wound dehiscence: improving prevention and outcomes. Wounds International, 2018
Timepoint [1] 321347 0
Day 1 to Day 30 post operative.
Secondary outcome [1] 374711 0
Perceptions of wound healing using Quality of life assessment using a validated questionnaire EuroQol EQ-5D (1).

(1) Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 2011;20(10):1727-36.
Timepoint [1] 374711 0
Day 30 post operative.

Eligibility
Key inclusion criteria
Consenting male or female adults who are scheduled to undergo an elective hip or knee arthroplasty.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics for baseline reporting
Parametric and non parametric tests for significance
Logistic regression to identify independent predictors associated with complications
Survivorship curve and risk analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/03/2020
Actual
Date of last participant enrolment
Anticipated
24/08/2020
Actual
Date of last data collection
Anticipated
24/11/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 303779 0
University
Name [1] 303779 0
University of Western Australia
Country [1] 303779 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Hackett Drive, Crawley
WA 6009
Country
Australia
Secondary sponsor category [1] 304889 0
None
Name [1] 304889 0
Address [1] 304889 0
Country [1] 304889 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304300 0
University of Westen Australia
Ethics committee address [1] 304300 0
35 Hackett Drive, Crawley, WA 6009
Ethics committee country [1] 304300 0
Australia
Date submitted for ethics approval [1] 304300 0
28/01/2020
Approval date [1] 304300 0
Ethics approval number [1] 304300 0

Summary
Brief summary
A safe and common surgical procedure; hip and knee arthroplasty (THA, TKA) is not immune to the occurrence of postoperative complications such as surgical site infection (SSI) or surgical wound dehiscence (SWD). While published rates of SSI following hip or knee arthroplasty are low, 1-2% in some cases, it is the resulting wound complication and its clinical management and the catastrophic impact to the patient’s wound healing and wellbeing and return to daily life that is of considerable concern. Complications such as surgical site infection and/or dehiscence following TKA and THA, often result in extended lengths of stay, readmission for further surgery, primary and community nursing visits, and are a costly burden to healthcare settings. To address the evidence gap for the early identification and prevention of postoperative wound complications in obese patients following hip or knee arthroplasty, a non randomized pragmatic trial is proposed which will utilize an advanced hydropolymer wound dressing coupled with smartphone technology for the early identification of complication and prevention. The advanced wound hydropolymer dressing is transparent and allows for complete visibility of the incision line. This allows the patient to send digital images of their incision line to the clinician who is able determine the healing progress of the participants surgical wound. The use of digital images of the wound sent to the clinician for assessment remotely and without removal of the dressing potentially removes the need for hospital readmission due the ability to diagnose a complication early and intervene. Furthermore, use of this patient engaged model empowers the patient in their wound healing.
This study will determine the feasibility of such a model in the post discharge setting to assist in reducing the number of hospital readmission due to surgical wound breakdowns, often diagnosed and treated too late to prevent the escalation to a catastrophic wound breakdown.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96446 0
Dr Kylie Sandy-Hodgetts
Address 96446 0
Burn Injury Research Unit,
School of Biomedical Sciences
Faculty of Medical and Health Sciences
CTEC Bldg, Entrance 2, Hackett Drive, Crawley,
University of Western Australia, WA 6009
Country 96446 0
Australia
Phone 96446 0
+61 8 6488 8587
Fax 96446 0
Email 96446 0
[email protected]
Contact person for public queries
Name 96447 0
Dr Kylie Sandy-Hodgetts
Address 96447 0
Burn Injury Research Unit,
School of Biomedical Sciences
Faculty of Medical and Health Sciences
CTEC Bld, Entrance 2, Hackett Drive, Crawley,
University of Western Australia, WA 6009
Country 96447 0
Australia
Phone 96447 0
+61 8 6488 8587
Fax 96447 0
Email 96447 0
[email protected]
Contact person for scientific queries
Name 96448 0
Dr Kylie Sandy-Hodgetts
Address 96448 0
Burn Injury Research Unit,
School of Biomedical Sciences
Faculty of Medical and Health Sciences
CTEC Bld, Entrance 2, Hackett Drive, Crawley,
University of Western Australia, WA 6009
Country 96448 0
Australia
Phone 96448 0
+61 8 6488 8587
Fax 96448 0
Email 96448 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be de-identified and available in aggregate form, however IPD will not be available due to Section 95A of the Privacy Act.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA non-randomised pragmatic trial for the early detection and prevention of surgical wound complications using an advanced hydropolymer wound dressing and smartphone technology: The EDISON trial protocol.2022https://dx.doi.org/10.1111/iwj.13823
N.B. These documents automatically identified may not have been verified by the study sponsor.