Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000400167p
Ethics application status
Not yet submitted
Date submitted
2/03/2019
Date registered
12/03/2019
Date last updated
18/06/2021
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient-controlled needle-free carbon dioxide insufflated breast expander implant (Aeroform®, AirXpanders®) in breast reconstruction: multi-surgeon prospective case series
Scientific title
Patient-controlled needle-free carbon dioxide insufflated breast expander implant (Aeroform®, AirXpanders®) in breast reconstruction: multi-surgeon prospective case series
Secondary ID [1] 297591 0
None
Universal Trial Number (UTN)
U1111-1229-5013
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast reconstruction 311850 0
Condition category
Condition code
Surgery 310447 310447 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insertion of patient-controlled needle-free carbon dioxide insufflated breast expander implants (Aeroform®, AirXpanders®)

The expander is inserted during a surgical procedure under general anaesthetic which takes approximately one hour. The incision used is generally the existing incision from the preceding mastectomy. After the surgical procedure, patients are usually discharged 1-2 days postop. There is a clinic visit one week and two weeks postop. If wound healing is satisfactory at the two-week visit, women are provided with the hand-held remote control and provided with training about the expansion process. Training is one-on-one with the surgeon and takes approximately 5 minutes. The patient is shown how to push the button, educated about the safety lockout features, and told to seek medical attention if there is excessive pain or changes in the wound such as gaping or redness. Training is supplemented with a take-home booklet, a product support phone helpline, and a product website if further information is required.

Patients are booked back into clinic every 4 weeks to check on progress. When expansion is complete, they are booked for the surgical procedure to replace the expander with their final implant. Expansion is complete when the expander has reached its full capacity (400cc for the small size, 600 cc for the medium size and 800cc for the large size) or when the patient has reached their desired breast size if this occurs earlier. The size of the expander largely depends on the patient's previous breast size, as this determines the size of the available skin pocket to hold the expander.

The surgeon will be performing the surgery and seeing the patient at the followup visits. Expansion will be carried out by the patient using the hand-held remote. The general anaesthetic for surgery will be proved as per the routine protocols at GCHealth. The actual drug doses, frequency, and mode of administration will be at the discretion of the anaesthetist of the day. Immediate postop routine analgesia includes regular paracetamol plus oral opiates as required (typically Endone 5mg q6h prn) with additional analgesia as charted by the acute pain team, which is part of the clinical pathway. After discharge home and through the expansion period, patients do not need anything more than paracetamol prn.

The expansion is initiated by the patient depending on their own comfort. 10cc of gas is released each time the button on the remote is pressed, there is a 3-hour lockout between doses, and a 24-hour lockout after the third dose. Other than this there is no 'schedule' and patients can expand as quickly or slowly as they wish. Adherence is not expected to be an issue as patients who undergo this surgery are usually very motivated to complete the expansion as part of their breast reconstruction journey. The AirXpander has a maximum duration of 6 months after insertion (the same as for saline expanders) but many patients have completed expansion at the first 4 week check. Previous experience with saline expanders show that non-completion of expansion is most commonly due to unexpected significant health events that make the patient unfit for further surgery, and not because the patient does not comply with treatment.

The device is a standard expander shell, but without a saline injection port. Instead, it contains a small canister containing compressed carbon dioxide which is actuated through a hand-held remote controller. With saline expanders, patients receive 100 mL injections of saline through the skin into the injection port. With the AirXpander, 10mL is released each time the button on the remote is pressed, capped at 30mL per 24 hours. Thus the previous 100mL volume can be delivered in 3.3 days. Previous studies also show that expansion times are shorter because it is possible to expand 210mL over 7 days- more than twice as much as a 100mL saline injection. So patients can expand faster or slower than the usual saline expansion schedule, in the comfort of their own homes, without further clinic visits or skin punctures. Breast size can also be very accurately calibrated because the AirXpander allows breast size to be changed by increments of 10mL, and patients can pause expansion for a few days to 'live with' their chosen breast size and decide if they wish to keep expanding or stop.
Intervention code [1] 313826 0
Treatment: Surgery
Intervention code [2] 313864 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319314 0
Safety- device related events, breast related events, other adverse events

Known/possible adverse events are the same as for existing saline expander.
Device-related events- failure to expand, device rupture, device leak
Breast-related events- infection, bleeding, flap necrosis, impaired wound healing, seroma
Other adverse events- pain beyond expected, venous thrombosis, pneumonia, cardiac event

These events will be gathered from the electronic medical record and cross-checked with complications logged in the monthly unit morbidity and mortality audit.
Timepoint [1] 319314 0
12 months (1 year) from first insertion of device
Secondary outcome [1] 367719 0
Efficacy- device success

Measured as a binary (yes/no) information gained from electronic medical record
Timepoint [1] 367719 0
12 months (1 year) from first insertion of device
Secondary outcome [2] 367870 0
Device success- time to completion of expansion

Measured in days from time of first surgery, information gained from electronic medical record
Timepoint [2] 367870 0
12 months (1 year) from insertion of device
Secondary outcome [3] 367871 0
Device success- time to second stage procedure

Measured in days from time of first surgery, information gathered from electronic medical record
Timepoint [3] 367871 0
12 months (1 year) from insertion of device

Eligibility
Key inclusion criteria
1) participant requires immediate or delayed breast reconstruction using expander implant
2) participant is over the age of 18
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) participant is unable to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Prospective consecutive case series
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Number of participant = 50.
This number has been chosen based on current patient numbers in the study unit and the previous largest single-surgeon trial in Australia (n=22)

Quantitative data (number of days) will be analysed with descriptive statistics. These will include measures of central tendency (mean, median, mode) and spread (standard deviation). Individual adverse effects and device success/failure will be described qualitatively.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Product withdrawn from market
Date of first participant enrolment
Anticipated
29/04/2019
Actual
Date of last participant enrolment
Anticipated
27/04/2020
Actual
Date of last data collection
Anticipated
26/04/2021
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13293 0
Robina Hospital - Robina
Recruitment hospital [2] 13294 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 25867 0
4226 - Robina
Recruitment postcode(s) [2] 25868 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 302141 0
Hospital
Name [1] 302141 0
Gold Coast Health
Country [1] 302141 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Gold Coast Breast Services
Address
1 Hospital Blvd, Southport, QLD 4215
Country
Australia
Secondary sponsor category [1] 301976 0
None
Name [1] 301976 0
Address [1] 301976 0
Country [1] 301976 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302820 0
Gold Coast Hospital and Health District Human Research Ethics Committee
Ethics committee address [1] 302820 0
1 Hospital Boulevard
Southport, QLD, 4215
Ethics committee country [1] 302820 0
Australia
Date submitted for ethics approval [1] 302820 0
13/03/2019
Approval date [1] 302820 0
Ethics approval number [1] 302820 0

Summary
Brief summary
A two-stage tissue expander–to-implant procedure is the most common implant-based reconstructive method, and accounted for 2868 procedures in Australia in 2016. The saline implant with self-sealing port was patented in 1980 by Radovan and requires serial bolus injections of saline to be administered by a clinician every few weeks after surgery. This process can be uncomfortable, lengthy, and logistically challenging for patients and clinics due to the need for ongoing recurrent appointments.

The AeroForm® tissue expander (AirXpanders® Inc., Palo Alto, California) is a remote-controlled, carbon dioxide–filled breast tissue expander. It was designed to provide women with a gradual, needle-free, controlled, and faster method of completing the expansion process. This system is composed of an implantable tissue expander containing a reservoir of compressed carbon dioxide, and an external hand-held remote control. The patient uses the controller to activate a valve within the reservoir to release carbon dioxide into the expander, eliminating the necessity for repeated injections and the associated clinic visits. The device is programmed to allow patient dosing in increments of 10 cm3. Multiple safety mechanisms are incorporated into the device design; only one 10cm3 dose of carbon dioxide may be administered during a 3-hour period, and no more than three doses (30 cm3) of carbon dioxide may be given per day.

The AeroForm® expander demonstrated successful expansion within 2 weeks with no adverse effects in a sheep model, and the first human trials, conducted in Australia, demonstrated 100 percent success rates in the Patient-Activated Controlled Expansion I and II (pilot and extended pilot) trials. These were single-surgeon trials. These early trials, supported with additional data from the Australian Aspirin to Prevent Recurrent Venous Thromboembolism trial, provided the basis for successful Therapeutic Goods Administration approval of the device in Australia.

The only randomised, controlled trial, AeroForm® Patient Activated controlled tissue expander (XPAND) has been performed in the United States, showing statistically significant shorter expansion and reconstruction times compared to saline implant, non-inferiority for safety with a 10 percent margin, and high rates of patient-rated ease, convenience, and satisfaction.

The purpose of this study is to undertake the first multi-surgeon case series in Australia. AeroForm® is already standard supply in Gold Coast Health, with very positive patient feedback about the convenience and comfort of patient-controlled inflation. However, it is very important to the surgeons of the unit that clinical outcomes are also satisfactory.
Trial website
Trial related presentations / publications
Public notes
Importantly, this trial is intended to be inclusive, reflecting real-world patients in a high volume breast unit. The inclusion and exclusion criteria have been kept to a minimum, in contrast to previously published trials which have often been restricted to populations which form a minority of our actual patients by excluding cancer indications, BMI >33, smokers, diabetics and so on. This may result in a wider range of treatment outcomes than previously published trials, but it is hoped that the information arising from this study will also be more realistic and applicable to the settings of other breast units around Australasia.

Contacts
Principal investigator
Name 91506 0
A/Prof Rhea Liang
Address 91506 0
Robina Hospital
2 Bayberry Lane, Robina, QLD 4226
Country 91506 0
Australia
Phone 91506 0
+61403449308
Fax 91506 0
Email 91506 0
[email protected]
Contact person for public queries
Name 91507 0
A/Prof Rhea Liang
Address 91507 0
Robina Hospital,
2 Bayberry Lane, Robina, QLD 4226
Country 91507 0
Australia
Phone 91507 0
+61403449308
Fax 91507 0
Email 91507 0
[email protected]
Contact person for scientific queries
Name 91508 0
A/Prof Rhea Liang
Address 91508 0
Robina Hospital,
2 Bayberry Lane, Robina, QLD 4226
Country 91508 0
Australia
Phone 91508 0
+61403449308
Fax 91508 0
Email 91508 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Start after first publication (anticipated ~December 2021)
End date 15 years later when data is destroyed as per institutional protocols ~April 2036
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
requirement to sign data access agreement


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1498Study protocol    377112-(Uploaded-02-03-2019-17-49-44)-Study-related document.docx



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.