Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002006224p
Ethics application status
Submitted, not yet approved
Date submitted
19/11/2018
Date registered
13/12/2018
Date last updated
13/12/2018
Date data sharing statement initially provided
13/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the effectiveness of negative pressure wound therapy in the at risk obstetric population for the prevention of surgical wound complications: The CYGNUS Trial.
Scientific title
EffiCacY of neGative pressure wound therapy in the preventioN of surgical woUnd complicationS in the cesarean section at risk population: a randomised multi-centre trial, the CYGNUS trial.
Secondary ID [1] 296223 0
None
Universal Trial Number (UTN)
U1111-1221-4474
Trial acronym
CYGNUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
surgical site infection 309858 0
surgical wound complications 309859 0
skin/other skin conditions 310577 0
Condition category
Condition code
Skin 308651 308651 0 0
Other skin conditions
Reproductive Health and Childbirth 309290 309290 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Negative pressure wound therapy (NPWT) applied over the surgical incision (C-section) is an advanced wound dressing. The NPWT device consists of a single patient use battery operated pump attached to a sterile dressing. A nominal negative pressure of 80mmHg is maintained at the wound surface through the dressing delivered by the pump. The control dressing does not deliver negative pressure therapy and is a sterile dressing covering the incision site. The surgeon/assisting surgeon/wound care clinician will apply the dressing in theatre once the incision is closed and prepared for the dressing. The dressing (intervention or control) will be applied following the surgical procedure.The intervention will remain in place for 7 days.
Intervention code [1] 312551 0
Prevention
Intervention code [2] 312552 0
Treatment: Devices
Comparator / control treatment
Standard practice using non negative pressure dressing this is an occlusive dressing to protect the incision site.
Control group
Active

Outcomes
Primary outcome [1] 308166 0
Surgical wound dehiscence as per the study definition: separation along any point of the incision, and confirmed by attending surgeon and wound clinician/nurse practitioner. Any separations of sutured margins along any point of the surgical incision line is deemed an event. Study definition is as per the World Union of Wound Healing Societies (WUWHS) Consensus Document. Surgical wound dehiscence: improving prevention and outcomes. Wounds International, 2018
Timepoint [1] 308166 0
Day 30 postoperative
Secondary outcome [1] 354125 0
Surgical site infection as defined by the Centers for Disease Control (CDC) definition as per clinical signs and symptoms and with further microbiological testing and confirmation.
Timepoint [1] 354125 0
Day 30 postoperative

Eligibility
Key inclusion criteria
Pregnant
Informed consent obtained
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Males
Non consenting patients

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomised
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
Descriptive statistics for baseline data
Chi-squared for tests of significance
Pearson's R for correlation
Receiver operater curve (ROC) for predictive power, with AUC Statistic

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
449
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12444 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 24731 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 300820 0
Commercial sector/Industry
Name [1] 300820 0
Convatec Ltd.
Country [1] 300820 0
United Kingdom
Primary sponsor type
University
Name
University of Western Australia
Address
University of Western Australia
School of Human Sciences
Hackett Drive, Crawley, WA, 6009
Country
Australia
Secondary sponsor category [1] 300368 0
None
Name [1] 300368 0
NIL
Address [1] 300368 0
NIL
Country [1] 300368 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301588 0
St John of God Hospital
Ethics committee address [1] 301588 0
St John of God Hospital
McCourt Street, Subiaco
Perth, WA, 6008
Ethics committee country [1] 301588 0
Australia
Date submitted for ethics approval [1] 301588 0
04/12/2018
Approval date [1] 301588 0
Ethics approval number [1] 301588 0
Ethics committee name [2] 302042 0
King Edward Memorial Hospital
Ethics committee address [2] 302042 0
King Edward Memorial Hospital
Railway Road
Subiaco, WA, 6008
Ethics committee country [2] 302042 0
Australia
Date submitted for ethics approval [2] 302042 0
17/12/2018
Approval date [2] 302042 0
Ethics approval number [2] 302042 0

Summary
Brief summary
This study will determine the efficacy of advanced negative pressure wound therapy compared to a standard dressing protocol in the prevention if surgical wound breakdown following c-section delivery. The benefit of the study is to prevent this complication and improve the health and well-being of the mother following c-section delivery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87486 0
Dr Kylie Sandy-Hodgetts
Address 87486 0
University of Western Australia
Faculty of Health Science
School of Human Sciences
Hackett Drive, Crawley, WA, 6009
Country 87486 0
Australia
Phone 87486 0
+61 0435436747
Fax 87486 0
Email 87486 0
[email protected]
Contact person for public queries
Name 87487 0
Dr Kylie Sandy-Hodgetts
Address 87487 0
University of Western Australia
Faculty of Health Science
School of Human Sciences
Hackett Drive, Crawley, WA, 6009
Country 87487 0
Australia
Phone 87487 0
+61 0435436747
Fax 87487 0
Email 87487 0
[email protected]
Contact person for scientific queries
Name 87488 0
Dr Kylie Sandy-Hodgetts
Address 87488 0
University of Western Australia
Faculty of Health Science
School of Human Sciences
Hackett Drive, Crawley, WA, 6009
Country 87488 0
Australia
Phone 87488 0
+61 0435436747
Fax 87488 0
Email 87488 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
Identifiable data will not be available for this study.


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
EmbaseEffectiveness of negative pressure wound therapy in the prevention of surgical wound complications in the cesarean section at-risk population: A parallel group randomised multicentre trial - The CYGNUS protocol.2020https://dx.doi.org/10.1136/bmjopen-2019-035727
N.B. These documents automatically identified may not have been verified by the study sponsor.