Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001275853
Ethics application status
Approved
Date submitted
13/06/2012
Date registered
10/12/2012
Date last updated
8/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of negative pressure wound therapy (NPWT) in the prevention of post-operative surgical wound dehiscence in at risk patients following abdominal surgery; a multicentre randomised control trial.
Scientific title
Effectiveness of negative pressure wound therapy (NPWT) in the prevention of post-operative surgical wound dehiscence in at risk patients following abdominal surgery; a multicentre randomised control trial.
Secondary ID [1] 280661 0
NIL
Universal Trial Number (UTN)
Trial acronym
EUROPA trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post surgical wound complications 286681 0
Condition category
Condition code
Skin 286984 286984 0 0
Other skin conditions
Surgery 288289 288289 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical negative pressure device, provides a negative pressure at the closed incision site (80mmHg). The device is applied following surgery for a wear time of 14 days.
Intervention code [1] 285070 0
Prevention
Intervention code [2] 286165 0
Treatment: Devices
Comparator / control treatment
Standard dressing protocol (no topical negative pressure)
Control group
Active

Outcomes
Primary outcome [1] 287321 0
Outcome will be assessed through the following clinical endpoints assessed by 2 independant clinicians
1. occurence of surgical wound dehiscence (compared to controls)
Timepoint [1] 287321 0
Day 30
Secondary outcome [1] 297899 0
The secondary outcomes will be the following clinical endpoints and measured by 2 independant clinicians;
1. Occurence of surgical site infection (superficial or deep) compared to controls
Timepoint [1] 297899 0
Day 14 post op
Secondary outcome [2] 300269 0
The secondary outcome of the study is to determine the occurrence of surgical site infection as per the CDC definition.
Timepoint [2] 300269 0
Day 30 post op

Eligibility
Key inclusion criteria
Consenting adults who are undergoing an abdominal surgical procedure that uses a midline laparotomy as the surgical entry.
Minimum age
19 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
peadiatrics, any patient under 18years of age, emergency admission

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be done using a random generator table.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/05/2016
Actual
14/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
652
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 285431 0
University
Name [1] 285431 0
Curtin University
Country [1] 285431 0
Australia
Funding source category [2] 293883 0
Government body
Name [2] 293883 0
CRC Wound Innovation
Country [2] 293883 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Hayman Road, Bentley WA 6845
Country
Australia
Secondary sponsor category [1] 284283 0
None
Name [1] 284283 0
Address [1] 284283 0
Country [1] 284283 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287440 0
St John of God Healthcare Group - Subiaco
Ethics committee address [1] 287440 0
Ethics committee country [1] 287440 0
Australia
Date submitted for ethics approval [1] 287440 0
11/04/2016
Approval date [1] 287440 0
13/04/2016
Ethics approval number [1] 287440 0
Protocol #860

Summary
Brief summary
Post operative wound healing plays a significant role in an individuals health and wellbeing following surgery. Current research has idenitifed that post surgical wound healing delays leads to increases in morbidity and mortality and increases the economic burden to wider healthcare system. The research will engage surgeons and clinicians in an interventional clinical trial of a negative pressure device, applied post-operatively to assist in the prevention of wound dehiscence and infection. The potential outcome of this trial will have a major impact in relation to post-surgical patient wound care and the potential to reduce the economic burden of post surgical wound dehiscence
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34304 0
Mrs Kylie Sandy-Hodgetts
Address 34304 0
Curtin University,
Hayman Road
Bentley WA 6845
Country 34304 0
Australia
Phone 34304 0
+61 08 9266 9897
Fax 34304 0
Email 34304 0
[email protected]
Contact person for public queries
Name 17551 0
Mrs Kylie Sandy-Hodgetts
Address 17551 0
Curtin University
School of Nursing and Midwifery
Hayman Road
Bentley
WA 6845
Country 17551 0
Australia
Phone 17551 0
+610892662571
Fax 17551 0
Email 17551 0
[email protected]
Contact person for scientific queries
Name 8479 0
Mrs Kylie Sandy-Hodgetts
Address 8479 0
Curtin University
Hayman Road
Bentley WA 6845
Country 8479 0
Australia
Phone 8479 0
+61 0892662571
Fax 8479 0
Email 8479 0
[email protected]

No information has been provided regarding IPD availability


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
EmbasePrevention of postsurgical wound dehiscence after abdominal surgery with NPWT: a multicentre randomised controlled trial protocol.2017https://dx.doi.org/10.12968/jowc.2017.26.Sup2.S23
N.B. These documents automatically identified may not have been verified by the study sponsor.