Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000598583
Ethics application status
Not yet submitted
Date submitted
19/05/2015
Date registered
9/06/2015
Date last updated
9/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of negative pressure wound therapy - PICO™ in the reduction of seroma formation following unilateral mastectomy, a case control study.
Scientific title
The effectiveness of negative pressure wound therapy in breast surgery patients compared to standard surgical dressing in the prevention of seroma formation following unilateral mastectomy.
Secondary ID [1] 286756 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PICO mastectomy study.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post operative seroma
 295125 0
wound healing 295185 0
Condition category
Condition code
Surgery 295368 295368 0 0
Other surgery
Cancer 295435 295435 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is a negative pressure wound care dressing (NPWT). Intervention is administered by the surgeon and remains in place for 7 days. One dressing change on Day 5 or as close to as determined by level of strikethrough. This dressing delivers negative pressure to the wound bed to secure the flap and facilitate tissue perfusion.
Intervention code [1] 291912 0
Treatment: Devices
Intervention code [2] 291972 0
Prevention
Comparator / control treatment
a) duration of intervention; 7 days
b) dressing change day 5 or as close to
The control group will receive a non negative pressure surgical dressing known as a standard surgical dressing (SSD) and will receive the same duration and dressing change regime.
Control group
Active

Outcomes
Primary outcome [1] 295109 0
Seroma formation as per the study definition (fluid collection under the mastectomy flap).
Timepoint [1] 295109 0
Day 5 postoperative
Secondary outcome [1] 314789 0
Seroma formation
Timepoint [1] 314789 0
Day 14 postoperative

Eligibility
Key inclusion criteria
Consenting females who are to undergo an elective unilateral mastectomy.
Minimum age
18 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Males
Non consenting patients
Females under 18 years of age

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)
This case control quasi randomised trial will recruit and consent patients prior to their surgery. The surgeon will recruit and consent participants. Participants will be allocated to either the intervention or control group through a sealed envelope technique in theatre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomised control trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As there is limited prevalence or incidence data to determine an effect size or conduct a power calculation the sample of 100 was derived to determine baseline data for larger trials.

Descriptive statistics
Logistic regression

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2015
Actual
Date of last participant enrolment
Anticipated
1/05/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3808 0
St John of God Hospital, Subiaco - Subiaco

Funding & Sponsors
Funding source category [1] 291300 0
Other
Name [1] 291300 0
The work undertaken by investigators is an in kind contribution.
Country [1] 291300 0
Australia
Primary sponsor type
Hospital
Name
St John of God Hosptial
Address
McCourt St Subiaco, WA, 6008
Country
Australia
Secondary sponsor category [1] 289983 0
University
Name [1] 289983 0
Curtin University
Address [1] 289983 0
Hayman Rd, Bentley, WA, 6845
Country [1] 289983 0
Australia
Other collaborator category [1] 278474 0
None
Name [1] 278474 0
NIL
Address [1] 278474 0
NIL
Country [1] 278474 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292867 0
SJGHC Subiaco
Ethics committee address [1] 292867 0
McCourt St, Subiaco, Perth, WA, 6845
Ethics committee country [1] 292867 0
Australia
Date submitted for ethics approval [1] 292867 0
06/06/2015
Approval date [1] 292867 0
Ethics approval number [1] 292867 0

Summary
Brief summary
Background

Postoperative delayed wound healing impacts on patient wellbeing and return to normal life and can result in intrinsic and extrinsic complications. Unilateral mastectomy impacts on patient healing as well as body image perspective and is further complicated by the diagnosis of cancer.

Aim of the study
The purpose of the study is to determine the effectiveness of negative pressure wound therapy on seroma formation following unilateral mastectomy.

Who is it for?
The study is for females about to undergo an elective unilateral mastectomy that consent to be in the study. Study participants are randomly allocated (by chance) to one of two groups. Participants in one group will receive a negative pressure dressing applied to their wound for 7 days, whilst participants in the other group will receive a standard surgical dressing. Patients will be followed-up for up to 30 days postoperatively to determine seroma formation during the post operative period.



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57418 0
Dr Corinne Jones
Address 57418 0
C/- SJGHC
McCourt Street,
Subiaco
Perth, Western Australia, 6008
Country 57418 0
Australia
Phone 57418 0
+610892662571
Fax 57418 0
Email 57418 0
[email protected]
Contact person for public queries
Name 57419 0
Kylie Sandy-Hodgetts
Address 57419 0
Curtin University
School of Nursing, Midwifery and Paramedicine
Hayman Road
Bentley, Perth
Western Australia, 6845
Country 57419 0
Australia
Phone 57419 0
+610892662571
Fax 57419 0
Email 57419 0
[email protected]
Contact person for scientific queries
Name 57420 0
Kylie Sandy-Hodgetts
Address 57420 0
Curtin University
School of Nursing, Midwifery and Paramedicine
Hayman Road
Bentley, Perth
Western Australia, 6845
Country 57420 0
Australia
Phone 57420 0
+61 08 92662571
Fax 57420 0
Email 57420 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo The study is currently in data analysis phase, the... [More Details]

Documents added automatically
No additional documents have been identified.