ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000004965

Ethics application status

Approved

Date submitted

10/09/2019

Date registered

8/01/2020

Date last updated

29/09/2024

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]

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

obesity

surgical site infection

Condition category

Condition code

Skin

Dermatological conditions

Infection

Studies of infection and infectious agents

Skin

Other skin conditions

Diet and Nutrition

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]

Early detection / Screening

Intervention code [2]

Prevention

Comparator / control treatment

This is a non randomised pragmatic trial that does not utilise a comparator.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Day 1 to Day 30 post operative.

Secondary outcome [1]

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]

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?

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

Completed

Date of first participant enrolment

Anticipated

24/03/2020

Actual

8/01/2024

Date of last participant enrolment

Anticipated

24/08/2020

Actual

26/09/2024

Date of last data collection

Anticipated

24/11/2020

Actual

26/09/2024

Sample size

Target

200

Accrual to date

Final

200

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Western Australia

Address [1]

35 Stirling Highway, Nedlands WA 6009

Country [1]

Australia

Primary sponsor type

University

Name

University of Western Australia

Address

35 Hackett Drive, Crawley
WA 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Westen Australia

Ethics committee address [1]

35 Hackett Drive, Crawley, WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/01/2020

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

St John of God Health Care Human Research Ethics Committee

Ethics committee address [2]

https://www.sjog.org.au/about-us/research/human-research-ethics-committee

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

20/11/2023

Approval date [2]

06/11/2023

Ethics approval number [2]

HREC#1843

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

Dr Kylie Sandy-Hodgetts

Address

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

Australia

Phone

+61 8 6488 8587

Fax

kylie.sandy-hodgetts@uwa.edu.au

Contact person for public queries

Name

Kylie Sandy-Hodgetts

Address

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

Australia

Phone

+61 8 6488 8587

Fax

kylie.sandy-hodgetts@uwa.edu.au

Contact person for scientific queries

Name

Kylie Sandy-Hodgetts

Address

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

Australia

Phone

+61 8 6488 8587

Fax

kylie.sandy-hodgetts@uwa.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	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 trial protocol.	2022	https://dx.doi.org/10.1111/iwj.13823

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically