Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy
Recruiting · NCT07365267 · Interventional (participants receive a specific treatment) · Lead sponsor: Xijing Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable mesh
What this trial is about
Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction. The study targets adult women undergoing total mastectomy for breast cancer followed by implant-based reconstruction. It aims to determine the utility of the 3D-printed biodegradable mesh in implant-based breast reconstruction, assess its influence on tissue regeneration, postoperative cosmetic result, and complication profile.
Who can take part
Age range
18 Years to 70 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Female breast cancer patients aged 18 to 70 years.
- Histopathologically confirmed invasive breast cancer, as defined by the latest ASCO/NCCN guidelines.
- Unable to undergo breast-conserving surgery or willing to undergo total mastectomy with immediate implant-based breast reconstruction.
- ECOG performance status of 0-1.
- Voluntary participation in the study and signing of the written informed consent form.
Exclusion criteria
- Age \>70 years.
- Metastatic breast cancer (Stage IV) at initial diagnosis.
- Multicentric, extensive, diffuse lesions, or inflammatory breast cancer.
- Tumor involvement of the nipple-areolar complex.
- Breast cancer during pregnancy.
- History of other malignancies within the past 5 years, except for cured cervical carcinoma in situ or non-melanoma skin cancer.
- Abnormal function of vital organs such as heart, lungs, liver, or kidneys; poorly controlled diabetes, etc., rendering the patient unable to tolerate surgery.
- Patients deemed unsuitable for participation by the investigator.
Where it is running
1 location listed.
- the First Affiliated Hospital of the Air Force Medical University - Xi'an, Shaanxi, China