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Trial registered on ANZCTR


Registration number
ACTRN12624000183583p
Ethics application status
Submitted, not yet approved
Date submitted
12/01/2024
Date registered
26/02/2024
Date last updated
26/02/2024
Date data sharing statement initially provided
26/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
DIEP flap assessment and monitoring using continuous visible light spectrometry.
Scientific title
A prospective study of deep inferior epigastric perforator (DIEP) flap viability assessment and monitoring using continuous visible light spectroscopy: A Pilot Study in women undergoing DIEP flap reconstruction procedure.
Secondary ID [1] 311022 0
X23-0162
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast reconstruction surgery via DIEP flap reconstruction technique 332567 0
Post-operational sleep quality 332568 0
Breast Cancer 332737 0
Condition category
Condition code
Surgery 329266 329266 0 0
Surgical techniques
Cancer 329457 329457 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intra-operative and post-operative DIEP flap continuous monitoring using the T-stat visible light spectroscopy device.

Monitoring using the T-stat device involves having the skin sensor patch stuck onto the skin of the DIEP flap (although it may be removed briefly for wound cleaning and dressing, to replace the patch, or for clinical observations or Doppler ultrasound monitoring). It will be placed on temporarily for monitoring during the operation, and constantly for 48 hours after the operation.

Patients would be provided with an information brochure about the device and a Participant Information Sheet that will explain details about their involvement in the study.

The device intervention will be performed by the research team who is also the medical care team of the participants. The team consisting of doctors and nurses will be trained (1x2hours session) prior to the study on the usage of the device by representatives of the device manufacturers, Spectros. Attendance of trained medical staff and researchers will be recorded, and only those who are trained will be involved in T-stat device manipulation during the study.

Device adherence will be monitored remotely. The device is connected remotely onto an app called OnCall which the surgeons will download on their smartphones.

There will not be any major operational difference due to the interventional except for the assessment of flap viability during the surgery where the interventional group will be assessed with the device placed onto the flap, while the control group will be assessed via sonography and observations.
Intervention code [1] 327763 0
Treatment: Devices
Intervention code [2] 327890 0
Early detection / Screening
Intervention code [3] 327891 0
Treatment: Surgery
Comparator / control treatment
Standard of care monitoring of DIEP flap with clinical flap examination (skin colour observations and capillary refill) and doppler sonography ultrasound at the following intervals:
Intra-operatively: Standard of care testing of venous and arterial insufficiency with doppler sonography.
Post-operatively: Clinical flap examination and doppler sonography ultrasound hourly for the first 48 hours and 4-hourly for the next 48 hours and subsequently 8-hourly till discharge.
Control group
Active

Outcomes
Primary outcome [1] 337088 0
Number of sleep awakenings in a 24-hours period
Timepoint [1] 337088 0
1 week pre-operation, days 1 to 14 post operation
Secondary outcome [1] 430635 0
Sleep quality
Timepoint [1] 430635 0
Sleep diary surveys taken at 1 week pre-operation and days 1 to 14 post-operation

PSQI survey measured 1 week pre-operation and 6 weeks post-operation
Secondary outcome [2] 431336 0
Patient satisfaction
Timepoint [2] 431336 0
Pre-operation week 1
Post-operation 6 weeks and 3 months
Secondary outcome [3] 431337 0
Post-operative pain
Timepoint [3] 431337 0
post-operative day 1-14
Secondary outcome [4] 431339 0
Flap complication rate
Timepoint [4] 431339 0
post-operative day 1 to discharge
Secondary outcome [5] 431340 0
Length of hospital stay
Timepoint [5] 431340 0
Post-operation day 1 till discharge.

Eligibility
Key inclusion criteria
1. Patient older than 18 years of age (no upper age limit)
2. Is about to undergo a DIEP flap reconstruction procedure (unilateral / bilateral) after diagnosis and treatment of breast cancer
3. Willing to provide consent and participate in the study, complying to all study requirements
4. Patients in the “learning curve”


"learning curve" group is defined as the group of first few participants using the T-stat device. As the research team is using this new device for the first time and are adjusting to the usage of this device, results of these "learning curve" group may not be the optimal, but we are still including them in this study as this is a pilot study with a small sample size to test the feasibility of the device and looking at the possibility of expanding into a future large trial with a greater pool of patients.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are unable to read and write in English to a level required for consent and completion of questionnaires.
2. Patient who are or potentially may be allergic to the T-stat device sensor patch.
3. Patients whose skin, due to a named or unnamed condition, presents with non-clear fluid production that may interfere with the light signal.
4. Patients who have an existing sleep disorder (e.g sleep apnoea, insomnia, parasomnias, restless leg syndrome) which can interfere with their judgement of their post-operative sleep quality.
5. Patients who have an existing mental disorder (e.g depression, anxiety) which may interfere with their ability to provide accurate responses to the SF-36 and Breast Q questionnaires.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by lot draws
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Demographic data of patients including age, gender, BMI, smoking status, peripheral vascular disease, and diabetic status will be summarised. For continuous variables, mean, standard deviation, median and range will be measured, while for categorical variables, frequency counts and percentages will be measured.
Descriptive analysis would be performed on all patient demographics and outcome variables. Simple student T-tests would be performed to investigate any differences in primary and secondary outcomes between the control and intervention groups. Mean and median number of sleep awakenings pre-operatively will be compared to each post-operative day, and to the total post-operative period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26013 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 41860 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 315284 0
Hospital
Name [1] 315284 0
Chris O'Brien Lifehouse
Country [1] 315284 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119-143 Missenden Road, Camperdown New South Wales 2050
Country
New Zealand
Secondary sponsor category [1] 317325 0
None
Name [1] 317325 0
Address [1] 317325 0
Country [1] 317325 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314206 0
Sydney Local Health District (SLHD) Clinical Trial Ethics Committee
Ethics committee address [1] 314206 0
Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [1] 314206 0
Australia
Date submitted for ethics approval [1] 314206 0
27/11/2023
Approval date [1] 314206 0
Ethics approval number [1] 314206 0

Summary
Brief summary
This study aims to evaluate if the use of the T-stat oximeter device for breast cancer patients undergoing DIEP flap reconstruction procedures can improve post-operative sleep quality. Patients above the age of 18 year old who are diagnosed and treated for breast cancer and are about to undergo a DIEP flap reconstruction procedure are eligible for this study after appropriate consent is obtained.

Participants will be randomised into either the control group or interventional group and are required to complete surveys at different timepoints of the study that evaluates sleep quality and quality of life. Control group patient will be monitored with current gold standard of care via observational and sonography ultrasounds while intervention group patients will under monitoring via the T-stat device.

Results of this study aims to better future care for breast cancer patients and reduce post-operative sleep disturbance related complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130782 0
Mr Joseph Dusseldorp
Address 130782 0
Clinic C, Level 2 Chris O’Brien Lifehouse 119-143 Missenden Rd Camperdown NSW 2050
Country 130782 0
Australia
Phone 130782 0
+61 02 8514 0690
Fax 130782 0
Email 130782 0
[email protected]
Contact person for public queries
Name 130783 0
Joseph Dusseldorp
Address 130783 0
Clinic C, Level 2 Chris O’Brien Lifehouse 119-143 Missenden Rd Camperdown NSW 2050
Country 130783 0
Australia
Phone 130783 0
+61 02 8514 0690
Fax 130783 0
Email 130783 0
[email protected]
Contact person for scientific queries
Name 130784 0
Joseph Dusseldorp
Address 130784 0
Clinic C, Level 2 Chris O’Brien Lifehouse 119-143 Missenden Rd Camperdown NSW 2050
Country 130784 0
Australia
Phone 130784 0
+61 02 8514 0690
Fax 130784 0
Email 130784 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21376Study protocol    386931-(Uploaded-02-02-2024-12-15-57)-Study-related document.docx
21377Informed consent form    386931-(Uploaded-12-01-2024-19-45-15)-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.