Pectus Excavatum Camouflage

N/AActive Not RecruitingNCT05451108

BellaSeno Pty Ltd7 enrolled

Overview

The clinical study is testing a new treatment for pectus excavatum called "custom-made 3D printed scaffold-based soft tissue reconstruction". The new method uses a combination of the patients own adipocytes (fat cells) with a 3D printed scaffold (PCL Pectus Scaffold) to support soft tissue regeneration in the patient's chest using the body's natural healing processes. The implanted scaffold acts as a resorbable frame to support the growth of cells. The substance used for the scaffold is resorbable, it's similar to the substance used for sutures and stitches, and it's already Therapeutic Goods Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the tissue in its place.

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 techniques, 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 implantation. 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.

Study Type

INTERVENTIONAL

Allocation

Interventions

PCL Pectus Scaffold implantation and autologous fat graftingDEVICE

A small incision is made in the chest and pre-sternal pocked is defined. Following this, an empty scaffold is implanted at the site of the defect with skin closed directly over it. At the same stage, autologous fat transfer will be performed, harvesting fat from available donor sites such as the thighs and abdomen - depending on scaffold volume and patient morphology. The area will be infiltrated with local anaesthetic tumescent fluid, liposuction performed, and fat transferred to syringes for filtration prior to injection into the scaffold. Fat will not be processed beyond simple filtration to separate liquid from fat to be injected. The scaffold provides structural stability to the chest during the infiltration of the tissue inside the scaffold.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 54 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Pectus excavatum defect 2. Patient aged ≥18 and \<55 years (patients 55 years and over may still be eligible pending assessment by investigating team and documentation of rationale) 3. Patient willing and able to comply with the study requirements. 4. Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia). 5. Patient capable of providing valid informed consent. Exclusion Criteria: 1. Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency. 2. 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. 3. Patient with unstable cardiac or respiratory function due to pectus excavatum or those requiring functional repair. 4. 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. 5. Patient with polycaprolactone (PCL) allergy 6. Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the pectus excavatum camouflage surgery. 7. Women of childbearing potential without an appropriate contraceptive method. 8. Patient with life expectancy \< 36 months.

Outcomes

Primary Outcomes

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 end of study visit) to ensure the safety of device and 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). These will be carefully evaluated by the principal investigator.

Time frame: Assessed daily during inpatient stay and at 1-week, at 1-,3-,6-,12-, 24-months and any relevant unscheduled visits post-surgery with 2 years post-surgery being the primary time-point.

Secondary Outcomes

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.

Time frame: Assessed pre-surgery and at 1-,3-,6-,12- and 24-months post-surgery.

Change in cardiorespiratory function from baseline to 1 month after surgery

Pre-operative exercise tolerance testing to confirm their suitability for the trial. This will be repeated after complete recovery from the operation (usually after \>4 weeks). Cardiorespiratory outcome will be assessed using baseline and post-operative cardiopulmonary exercise. Standard Cardio-Pulmonary Exercise Testing (CPET) protocol will be applied and validated by a physician.

Time frame: Assessed pre-surgery and at 1-month post-surgery.

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). It will be tracked in the inpatient setting as well as at post-operative outpatient reviews.

Time frame: Assessed pre-surgery, during inpatient stay and at 1-week, at 1-,3-,6-,12- and 24-months and any relevant unscheduled visits post-surgery.

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.

Time frame: Assessed during inpatient stay and at 1-week and at 1-month post-surgery.

Change in patient quality of life as assessed by Quality of Life (QoL) questionnaires from baseline to the end of study visit

The Nuss questionnaire modified for adults (NQ-mA) and the 36-item Short Form Quality of Life (SF-36) questionnaire will be used to assess patient reported functional outcomes from the intervention. A combination of the NQ-mA and the SF-36 questionnaires provides a platform for comparison of the method proposed in this study against the current gold standard surgical management of pectus excavatum, as well as measuring the relative impact on health-related quality of live compared to interventions in other clinical scenarios.

Time frame: Assessed pre-surgery and at the 3-, 6-, 12- and 24-month clinical reviews.