3D-printed biodegradable mesh for one-stage implant breast reconstruction after mastectomy
Official title: 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
Run by Xijing Hospital · NCT07365267 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 25 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Status | Recruiting |
| Started | January 15, 2026 |
| Main results expected | June 30, 2028 |
| Study ends | December 1, 2028 |
| Registry record updated | January 26, 2026 |
| Trial ID | NCT07365267 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
the First Affiliated Hospital of the Air Force Medical University
Xi'an, Shaanxi, China Recruiting
Study contacts
- Study coordinator: Ju Liang Zhang, Prof.
- Email: vascularzhang@163.com
- Phone: 029-84775271
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.