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Trial registered on ANZCTR


Registration number
ACTRN12619000785101
Ethics application status
Approved
Date submitted
20/05/2019
Date registered
28/05/2019
Date last updated
24/07/2020
Date data sharing statement initially provided
28/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Negative Pressure Wound Therapy to Reduce Incisional Wound Infections - A Randomised Control Trial
Scientific title
Negative Pressure Wound Therapy to Reduce Incisional Wound Infections - A Randomised Control Trial
Secondary ID [1] 298291 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emergency Laparotomy 312917 0
Wound Infection 312952 0
Condition category
Condition code
Surgery 311411 311411 0 0
Other surgery
Infection 311441 311441 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Negative pressure wound therapy in the form of a Prevena Incision Management System (Prevena 20cm Peel & Place Dressing, and Prevena Customizable Dressing) will be placed on closed emergency laparotomy wounds at the time of surgery. The dressing will be left on the wound for seven days post-operatively and will be monitored daily by inpatient nursing staff.
Intervention code [1] 314527 0
Treatment: Devices
Comparator / control treatment
Standard dressing in the form of Opsite Post-Op Visible dressing will be placed on closed emergency laparotomy wounds for seven days post-operatively.
Control group
Active

Outcomes
Primary outcome [1] 320130 0
Surgical site infection (SSI) Rate (percentage). This will be assessed by a blinded surgeon at 2 and 4 week post-operative outpatient appointments.
Timepoint [1] 320130 0
2 weeks post-operation, 4 weeks post-operation (primary endpoint)
Secondary outcome [1] 370655 0
Wound epithelialisation rate. This will be assessed by a blinded surgeon at 4 weeks post-operation and the wound deemed either fully epithelialised or not fully epithelialised.
Timepoint [1] 370655 0
4 weeks post surgery
Secondary outcome [2] 370656 0
Patient and Observer Scar Assessment Scale
Timepoint [2] 370656 0
2 and 4 weeks post surgery

Eligibility
Key inclusion criteria
Emergency laparotomy where wound is closed primarily
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to consent to participation in trial

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
10/06/2019
Actual
2/03/2020
Date of last participant enrolment
Anticipated
10/06/2021
Actual
21/03/2020
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13806 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 26557 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 302832 0
Hospital
Name [1] 302832 0
The Northern Hospital
Country [1] 302832 0
Australia
Funding source category [2] 306294 0
Commercial sector/Industry
Name [2] 306294 0
KCI (part of 3M Health Care)
Country [2] 306294 0
Australia
Primary sponsor type
Individual
Name
Neil Strugnell
Address
The Northern Hospital
185 Cooper Street, Epping VIC 3076
Country
Australia
Secondary sponsor category [1] 302780 0
Hospital
Name [1] 302780 0
The Northern Hospital
Address [1] 302780 0
185 Cooper Street, Epping VIC 3076
Country [1] 302780 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303412 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 303412 0
145 Studley Road
PO Box 5555 Heidelberg Victoria 3084
Ethics committee country [1] 303412 0
Australia
Date submitted for ethics approval [1] 303412 0
Approval date [1] 303412 0
24/01/2019
Ethics approval number [1] 303412 0

Summary
Brief summary
This is a randomised controlled trial comparing negative pressure wound therapy (Prevena) with standard dressings for emergency laparotomy. The objective of the trial is to determine whether a negative pressure dressing reduces rates of surgical site infection and wound-related morbidity. This is a single-site study which aims to recruit 200 participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93586 0
Mr Neil Strugnell
Address 93586 0
The Northern Hospital
185 Cooper Street, Epping VIC 3076
Country 93586 0
Australia
Phone 93586 0
+61384052084
Fax 93586 0
+61384052587
Email 93586 0
[email protected]
Contact person for public queries
Name 93587 0
Neil Strugnell
Address 93587 0
The Northern Hospital
185 Cooper Street, Epping VIC 3076
Country 93587 0
Australia
Phone 93587 0
+61384052084
Fax 93587 0
+61384052587
Email 93587 0
[email protected]
Contact person for scientific queries
Name 93588 0
Neil Strugnell
Address 93588 0
The Northern Hospital
185 Cooper Street, Epping VIC 3076
Country 93588 0
Australia
Phone 93588 0
+61384052084
Fax 93588 0
+61384052587
Email 93588 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


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
No additional documents have been identified.