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Trial registered on ANZCTR


Registration number
ACTRN12621000798864
Ethics application status
Approved
Date submitted
31/03/2021
Date registered
24/06/2021
Date last updated
30/08/2024
Date data sharing statement initially provided
24/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical trial evaluating medical-grade polycaprolactone- PCL Pectus scaffold implantation with autologous fat grafting for pectus excavatum camouflage
Scientific title
Clinical trial evaluating feasibility and safety of medical-grade polycaprolactone-PCL Pectus scaffold implantation with autologous fat grafting for pectus excavatum camouflage
Secondary ID [1] 303749 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pectus excavatum 321209 0
Soft tissue defect 321417 0
Condition category
Condition code
Surgery 319177 319177 0 0
Surgical techniques
Musculoskeletal 319512 319512 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 3D printed scaffold made of medical grade polycaprolactone is planned to be implanted to correct pectus excavatum defects. First the patient will be thoroughly evaluated with history taking, examination and medical imaging to determine whether they are suitable for implantation. Imaging will take place as part of the work-up for the trial in the form of a CT scan and MRI. If the patient is deemed suitable for the trial, a custom-made scaffold for the patient chest wall defect is designed based on the medical imaging attained previously. This scaffold is then manufactured and sterilised, before being implanted.

The implantation surgery will be done at a tertiary teaching hospital by an experienced plastic and reconstructive surgeon. During the implantation procedure, the patient's own fat cells are harvested through simple liposuction tecnhniques, usually from the abdomen and thighs depending on the availability of the tissue. The fat cells that are harvested are then injected into the implanted scaffold at the time of implanation. The total length of procedure is estimated to take 1 hour.

The patients progress will be evaluated daily after the procedure while they are in hospital with clinical assessment of the wounds and overall status. On discharge a number of surveys will be performed to document the progress at regular intervals, as well as recurrent MRI studies.

The effectiveness, complications and side-effects will be monitored for up to two years.

All appointments and clinical assessment will be documented in the electronic patient medical record as well as a secure de-identified trial database.
Intervention code [1] 320156 0
Treatment: Surgery
Intervention code [2] 320157 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327051 0
Assessment of occurrence and type of SADE and AEs related to the surgical procedure or the device (e.g. vital signs, physical exam findings and cardiorespiratory function from baseline to the end of study visit) to ensure the safety of the device and the procedure. Clinical safety will be assessed by documenting all adverse events regardless of whether they are related to the trial in an adverse events report form - described in detail in the case report form (CRF). Adverse events are defined as per EN ISO 14155:2020. These will be carefully evaluated by the principal investigator.
Timepoint [1] 327051 0
Assessed daily during inpatient stay and at 1-week, 1-, 3-, 6-, 12-, 24-months and any relevant unscheduled visits post-surgery with 2 years post-surgery being the primary time-point.
Secondary outcome [1] 396317 0
Change in patient quality of life as assessed by QoL questionnaires from baseline to the end of study visit. The 36-item Short Form Quality of Life (SF-36) questionnaire will be used to assess patient reported functional outcomes from the intervention.
Timepoint [1] 396317 0
Assessed pre-surgery and at 3-, 6-, 12- and 24-months post-surgery.
Secondary outcome [2] 397314 0
Change in patient quality of life as assessed by QoL questionnaires from baseline to the end of study visit. The Nuss Questionnaire modified for Adults (NQ-mA) questionnaire will be used to assess patient reported functional outcomes from the intervention.
Timepoint [2] 397314 0
Assessed pre-surgery and at 3-, 6-, 12- and 24-months post-surgery.
Secondary outcome [3] 411494 0
Change in (fat) volume, soft tissue retention and tissue integration from the time of surgery to the end of study visit using radiological and clinical assessments. Fat volume, soft tissue retention and tissue integration will be evaluated by a senior radiologist utilising serial MRI imaging with assessment of soft tissue volume using a standardised segmentation protocol. Imaging will be taken at regular intervals in conjunction with clinical visits as defined by the protocol. This is a composite secondary outcome.
Timepoint [3] 411494 0
Assessed pre-surgery and at 1-,3-,6-,12- and 24-months post-surgery.
Secondary outcome [4] 411495 0
Change in cardiorespiratory function from baseline to 1 month after surgery. Cardiorespiratory outcomes will be assessed using baseline and post-operative cardiopulmonary exercise testing (CPET). Standard Cardio-Pulmonary Exercise Testing (CPET) protocol will be applied and validated by a physician. Parameters recorded will include Vital signs, VO2 Max and constant electrocardiogram monitoring to detect right heart strain.
Timepoint [4] 411495 0
Pre-surgery and 1 month post surgery for repeat assessment.
Secondary outcome [5] 411496 0
Change in pain assessments from baseline to the end of study visit. Pain will be assessed with the Numerical Pain Rating system from 0 (no pain at all) to 10 (worst imaginable pain).
Timepoint [5] 411496 0
Assessed pre-surgery, during inpatient stay and at 1-week, at 1-,3-,6-,12-,24-months and any relevant unscheduled visits post-surgery.
Secondary outcome [6] 411497 0
Change in wound healing from the time of surgery to 1 month after surgery. Wound status will be assessed with the Holger Classification for wounds.
Timepoint [6] 411497 0
Assessed during inpatient stay and at 1-week and at 1-month post-surgery.
Secondary outcome [7] 411498 0
Observational assessment of histological measures following secondary AFG if patients undergo subsequent fat grafting (general tissue morphology and micropathology, adipose tissue viability, angiogenesis and immune activity). These data can be correlated with medical imaging, as well as previous data gained from pre-clinical animal models.
Timepoint [7] 411498 0
Assessed at 24-months post-surgery.
Secondary outcome [8] 439230 0
Observational and descriptive assessment of clinical photographs, videos and 3D surface scan of the upper torso and chest fields from the time of surgery to the end of study visit.
The aesthetic changes will be evaluated utilising standardised serial pictures, videos and 3D scans with a comparison of the outcome over time. Pictures, videos and 3D scans will be taken at regular intervals in conjunction with clinical visits.
Timepoint [8] 439230 0
Secondary outcome [9] 439231 0
Observational and descriptive assessment of clinical photographs, videos and 3D surface scan of the upper torso and chest fields from the time of surgery to the end of study visit.
The aesthetic changes will be evaluated utilising standardised serial pictures, videos and 3D scans with a comparison of the outcome over time. Pictures, videos and 3D scans will be taken at regular intervals in conjunction with clinical visits.
Timepoint [9] 439231 0
Assessed pre-surgery and at 1-week, at 1-,3-,6-,12- and 24-months post-surgery.
Secondary outcome [10] 439232 0
Observational assessment of health economic measures from the time of surgery to the end of study visit (hospital length of stay, ICU length of stay, operative time, blood loss during surgery (mL)).
Length of admission, blood loss during surgery (mL), operative time and complications will be monitored throughout the trial to provide a guide for optimisation of current protocols and potential translation into use of PCL scaffolds for reconstruction in broader clinical settings.
Timepoint [10] 439232 0
Assessed pre-surgery and at 1-week, at 1-,3-,6-,12- and 24-months post-surgery.
Secondary outcome [11] 439233 0
Observational assessment of health economic measures from the time of surgery to the end of study visit (hospital length of stay, ICU length of stay, operative time, blood loss during surgery (mL)).
Length of admission, blood loss during surgery (mL), operative time and complications will be monitored throughout the trial to provide a guide for optimisation of current protocols and potential translation into use of PCL scaffolds for reconstruction in broader clinical settings.
Timepoint [11] 439233 0
Assessed at 24-months post-surgery.

Eligibility
Key inclusion criteria
o Pectus excavatum defect
o Patient aged >18 and <55 years, inclusive, (patients 55 years and over may still be eligible pending assessment by investigating team and documentation of rationale)
o Patient willing and able to comply with the study requirements.
o Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
o Patient capable of providing valid informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
o Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
o Patient with known severe concurrent or inter-current illness including cardiovascular, respiratory or immunological illness, psychiatric disorders, alcohol or chemical dependence, possible allergies that would, in the opinion of the Principal Investigator, compromise their safety or compliance or interfere with interpretation of study results.
o Patient with unstable cardiac or respiratory function due to pectus excavatum or those requiring functional repair.
o Patients with Body Mass Index (BMI) below 18.5 kg/m2 and above 30 kg/m2. NB: Patients with BMI up to 10% higher than the upper limit (up to 33 kg/m2) can be still enrolled if the treating surgeon confirms that BMI is not associated with any kind of pathology.
o Patient with Polycaprolactone (PCL) allergy
o Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the pectus excavatum camouflage surgery.
o Women of childbearing potential without an appropriate contraceptive method.
o Patient life expectancy < 36 months.

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)
Allocation not concealed
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
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All patients consented for the trial will be accounted for in the analysis (intention to treat). Statistical analysis will include descriptive statistics for demographic, primary and secondary outcomes at each time point. Comparison analysis of questionnaire results between timepoints and time to event univariate Cox regression analysis will be performed due the small sample size. Statistical significance will be defined as P < 0.05. Data will be analysed using SPSS for Windows v.22 (SPSS, Chicago, Illinois, USA).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/12/2021
Actual
10/12/2021
Date of last participant enrolment
Anticipated
29/02/2024
Actual
24/07/2023
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
10
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19049 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 33597 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 308156 0
Commercial sector/Industry
Name [1] 308156 0
Bellaseno Pty Ltd
Country [1] 308156 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BellaSeno Pty Ltd
Address
16 Nexus Way,
Southport
QLD 4215
Country
Australia
Secondary sponsor category [1] 311846 0
None
Name [1] 311846 0
Address [1] 311846 0
Country [1] 311846 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308141 0
metro south human research ethics committee (EC00167)
Ethics committee address [1] 308141 0
Ethics committee country [1] 308141 0
Australia
Date submitted for ethics approval [1] 308141 0
16/03/2021
Approval date [1] 308141 0
07/06/2021
Ethics approval number [1] 308141 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109678 0
Dr Michael Wagels
Address 109678 0
Department of Plastic & Reconstructive Surgery Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba
Brisbane, Queensland 4102
Country 109678 0
Australia
Phone 109678 0
+61406183619
Fax 109678 0
Email 109678 0
michael.wagels@health.qld.gov.au
Contact person for public queries
Name 109679 0
Michael Wagels
Address 109679 0
Department of Plastic & Reconstructive Surgery Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba
Brisbane, Queensland 4102
Country 109679 0
Australia
Phone 109679 0
+61406183619
Fax 109679 0
Email 109679 0
michael.wagels@health.qld.gov.au
Contact person for scientific queries
Name 109680 0
Michael Wagels
Address 109680 0
Department of Plastic & Reconstructive Surgery Princess Alexandra Hospital
199 Ipswich Rd, Woolloongabba
Brisbane, Queensland 4102
Country 109680 0
Australia
Phone 109680 0
+61406183619
Fax 109680 0
Email 109680 0
michael.wagels@health.qld.gov.au

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
11250Study protocol  michael.wagels@health.qld.gov.au
11251Informed consent form  michael.wagels@health.qld.gov.au



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.