ACTRN12622000147785进行中（未招募）未知
Clinical trial evaluating feasibility and safety of medical-grade polycaprolactone-PCL breast scaffold implantation with autologous fat grafting for breast implant revision and congenital defect correction surgery
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1. Females over the age of 18 requiring pre-pectoral breast implant revision or congenital defect correction surgery, unilateral or bilateral.
- •2. Patient willing and able to comply with the study requirements.
- •3. Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
- •4. Patient capable of providing valid informed consent.
- •5. Patient has sufficient body fat for homologous transplantation.
- •; 1. Females over the age of 18 requiring pre-pectoral breast implant revision or congenital defect correction surgery, unilateral or bilateral.
- •2. Patient willing and able to comply with the study requirements.
- •3. Patient is eligible to undergo MRI (i.e., no implanted incompatible metal or metal devices, no history of severe claustrophobia).
- •4. Patient capable of providing valid informed consent.
- •5. Patient has sufficient body fat for homologous transplantation.
排除标准
- •Patients may not participate in the clinical investigation if they meet ANY of the following criteria:
- •1. Patients who have undergone Radical Mastectomy or radical removal of chest wall soft tissue.
- •2. Patients who have had breast or chest wall irradiation.
- •3. Prior history of infection in the breast region in the preceding 12 months.
- •4. Patients diagnosed with or having a prior history of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
- •5. The patient has any condition or disease, including uncontrolled diabetes (e.g., HbA1c > 8%), that is clinically known to impact wound healing ability.
- •6. Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
- •7. 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 Co-ordinating Principal Investigator, compromise their safety or compliance or interfere with interpretation of study results.
- •8. Body mass Index (BMI) below 20 and above 30 (patients with a BMI above 30 may still be eligible pending assessment by investigating team and documentation of rationale).
- •9. Polycaprolactone (PCL) allergy
- •10. Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the breast surgery.
- •11. Patient ineligible to undergo MRI.
- •12. Patient unable or unwilling to comply with the treatment protocol.
- •13. Patient unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment.
- •14. Patients with a history of smoking (patients with a history of smoking may still be eligible pending assessment by investigating team and documentation of rationale)
- •; Patients may not participate in the clinical investigation if they meet ANY of the following criteria:
- •1. Patients who have undergone Radical Mastectomy or radical removal of chest wall soft tissue.
- •2. Patients who have had breast or chest wall irradiation.
- •3. Prior history of infection in the breast region in the preceding 12 months.
- •4. Patients diagnosed with or having a prior history of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
- •5. The patient has any condition or disease, including uncontrolled diabetes (e.g., HbA1c > 8%), that is clinically known to impact wound healing ability.
- •6. Patient with a known history of immunodeficiency including HIV, concomitant systemic corticosteroid therapy, chemotherapy, synchronous haematological malignancy or other cause for secondary/primary immunodeficiency.
- •7. 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 Co-ordinating Principal Investigator, compromise their safety or compliance or interfere with interpretation of study results.
- •8. Body mass Index (BMI) below 20 and above 30 (patients with a BMI above 30 may still be eligible pending assessment by investigating team and documentation of rationale).
- •9. Polycaprolactone (PCL) allergy
- •10. Women who are currently pregnant or breast feeding, or who are planning to become pregnant within two years after the breast surgery.
- •11. Patient ineligible to undergo MRI.
- •12. Patient unable or unwilling to comply with the treatment protocol.
- •13. Patient unwilling or unable to provide fully informed consent including but not limited to patients with intellectual or mental impairment.
- •14. Patients with a history of smoking (patients with a history of smoking may still be eligible pending assessment by investigating team and documentation of rationale)
研究者
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