Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001314415
Ethics application status
Approved
Date submitted
13/09/2016
Date registered
19/09/2016
Date last updated
19/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Microporous Polysaccharide Hemospheres (MPH) and Seroma Formation After Mastectomy and Sentinel Node Biopsy/Axillary Dissection
Scientific title
Microporous Polysaccharide Hemospheres (MPH) and Seroma Formation After Mastectomy and Sentinel Node Biopsy/Axillary Dissection
Secondary ID [1] 290145 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 300264 0
Condition category
Condition code
Cancer 300131 300131 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
100 sequential patients are randomly assigned to control (n = 50) or experimental groups (n = 50).
The patients in the experimental group receive the MPH powder (1 gram) topically throughout the wound bed prior to closure, whereas the patients assigned to the control group receive no treatment.
Incisions are closed with interrupted dermal sutures with Vicryl 2/0 and a running subcuticular stitch of Monocryl 3/0.
Pressure dressings (Combine and Hypafix) are used overnight.
Drains are not used.
The patients are examined at their first clinic appointment (5-10 days post operatively) for the presence of a seroma and any palpable fluid collections were aspirated percutaneously.
Subsequent seroma aspiration timing and volumes are recorded.
Intervention code [1] 295896 0
Prevention
Comparator / control treatment
100 sequential patients are randomly assigned to control (n = 50) or experimental groups (n = 50).
The patients in the experimental group receive the MPH powder (1 gram) topically throughout the wound bed prior to closure, whereas the patients assigned to the control group receive no treatment.
Incisions are closed with interrupted dermal sutures with Vicryl 2/0 and a running subcuticular stitch of Monocryl 3/0.
Pressure dressings (Combine and Hypafix) are used overnight.
Drains are not used.
The patients are examined at their first clinic appointment (5-10 days post operatively) for the presence of a seroma and any palpable fluid collections were aspirated percutaneously.
Subsequent seroma aspiration timing and volumes are recorded.
Control group
Active

Outcomes
Primary outcome [1] 299614 0
Seroma- This is assessed by physical examination by the doctor or nurse seeing the patient at the appointment.
Timepoint [1] 299614 0
2 weeks
Primary outcome [2] 299659 0
Seroma volume- If the seroma is clinically significant and aspirated, the amount aspirated will be recorded.
Timepoint [2] 299659 0
2 weeks
Secondary outcome [1] 327690 0
Nil
Timepoint [1] 327690 0
Nil

Eligibility
Key inclusion criteria
The patients will be recruited sequentially from the breast clinics at Robina Hospital (ie women aged over 18 presenting with confirmed invasive or in-situ breast cancer who decide to proceed with a mastectomy +/- axillary surgery).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Reconstructive surgery

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)
No
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
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6660 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 14286 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 294514 0
Hospital
Name [1] 294514 0
Robina Hospital
Country [1] 294514 0
Australia
Funding source category [2] 294525 0
Commercial sector/Industry
Name [2] 294525 0
Bard Australia
Country [2] 294525 0
Australia
Primary sponsor type
Individual
Name
Diana Tam
Address
Robina Hospital
2 Bayberry Lane
Robina 4226
Queensland
Country
Australia
Secondary sponsor category [1] 293378 0
Commercial sector/Industry
Name [1] 293378 0
Bard Australia
Address [1] 293378 0
22 Lambs Road
Artarmon NSW 2064
Country [1] 293378 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295949 0
Gold Coast Hospital
Ethics committee address [1] 295949 0
Clinical Governance, Education and Research
Level 2 Block E Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Ethics committee country [1] 295949 0
Australia
Date submitted for ethics approval [1] 295949 0
06/04/2016
Approval date [1] 295949 0
13/09/2016
Ethics approval number [1] 295949 0
HREC/16/QGC/114

Summary
Brief summary
The primary purpose of this trial is to investigate whether the use microporous polysaccharide hemosphere (MPH) reduces the rate of seroma formation in breast cancer patients following mastectomy.

Who is it for?
You may be eligible to enrol in this trial if you are aged over 18 and have been diagnosed with breast cancer for which you are scheduled to undergo a mastectomy with or without sentinel lymph node biopsy, and with or without axillary lymph node dissection.

Study details
All participants enrolled in this trial will be randomly allocated (by chance) to receive either MPH or no MPH applied to the wound prior to wound closure. All participants will be followed up at 2 weeks following surgery to assess the wound site for seroma (fluid pockets).

It is hoped that this trial will provide information on whether MPH is effective in the prevention of seroma in breast cancer patients following mastectomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69026 0
Dr Diana Tam
Address 69026 0
Robina Hospital
2 Bayberry Lane
Robina QLD 4226
Country 69026 0
Australia
Phone 69026 0
+61 402785491
Fax 69026 0
Email 69026 0
[email protected]
Contact person for public queries
Name 69027 0
Dr Diana Tam
Address 69027 0
Robina Hospital
2 Bayberry Lane
Robina QLD 4226
Country 69027 0
Australia
Phone 69027 0
+61 402785491
Fax 69027 0
Email 69027 0
[email protected]
Contact person for scientific queries
Name 69028 0
Dr Diana Tam
Address 69028 0
Robina Hospital
2 Bayberry Lane
Robina QLD 4226
Country 69028 0
Australia
Phone 69028 0
+61402785491
Fax 69028 0
Email 69028 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
No additional documents have been identified.