3D-printed biodegradable mesh for one-stage implant breast reconstruction after mastectomy

Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy :A Prospective, Single-Center, Single-Arm Clinical Study

This trial will test whether a 3D-printed biodegradable mesh helps adult women having immediate implant breast reconstruction after mastectomy achieve better cosmetic results and a safe recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07365267 on ClinicalTrials.gov

What this trial studies

This single-center interventional study enrolls adult women (18–70) with invasive breast cancer who are undergoing total mastectomy and immediate implant-based reconstruction. Participants receive a silicone implant combined with a 3D-printed biodegradable biological mesh and undergo standardized preoperative imaging and baseline BREAST-Q and quality-of-life assessments. Primary outcomes include postoperative aesthetic outcome and safety, with secondary outcomes measuring quality of life and breast cancer–free interval during follow-up. Surgical technique, imaging, and patient-reported outcomes are used to characterize tissue regeneration, cosmetic result, and the complication profile.

Who should consider this trial

Good fit: Women aged 18–70 with histologically confirmed invasive breast cancer who are planned for total mastectomy with immediate implant-based reconstruction and have ECOG 0–1 may be eligible.

Not a fit: Patients with metastatic disease, multicentric or inflammatory tumors, nipple-areolar complex involvement, pregnancy, serious organ dysfunction, or those unsuitable for implant reconstruction are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the mesh could improve cosmetic contour and support tissue integration while reducing long-term foreign-body issues compared with permanent materials.

How similar studies have performed: Biological meshes and acellular dermal matrices have shown clinical benefit in implant-based reconstruction, but the use of 3D-printed biodegradable biological meshes is relatively novel with limited published clinical data.

Eligibility criteria

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 this trial is running

Xi'an, Shaanxi

• the First Affiliated Hospital of the Air Force Medical University — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Ju Liang Zhang, Prof.

Conditions Breast Cancer; Breast Reconstruction After Mastectomy; 3D-Printed Biodegradable Biological Mesh; breast reconstruction