Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision

Regenerative High Purity Type I Collagen Scaffold for Breast Cancer Excision Repair and Reconstruction: A Prospective Multicenter Clinical Trial

This clinical trial evaluates the safety and efficacy of High Purity Type I Collagen scaffold for breast volume restoration following breast-conserving surgery (BCS). The regenerative collagen matrix serves as a biocompatible scaffold promoting tissue ingrowth, neovascularization, and gradual remodeling, thereby improving cosmetic outcomes and patient quality of life after partial mastectomy.

Breast-conserving surgery (BCS) is the standard treatment for early-stage breast cancer, balancing oncological safety with aesthetic preservation. However, postoperative volume defects may cause breast asymmetry and psychological distress. Traditional options such as flaps or implants are limited by donor-site morbidity and complications.

This prospective, single-arm, bi-centre study investigates the clinical performance of a high-purity, cross-linked bovine Type I collagen scaffold for immediate breast volume restoration. The study will assess safety, volume maintenance, cosmetic appearance, and patient-reported outcomes through standardized 3D imaging, MRI analysis, and validated quality-of-life instruments.

The study will enroll 40 women undergoing BCS with expected volume defects ≥20%, with 2-month postoperative follow-up for primary endpoints.

Inclusion Criteria:

• Female, 18-70 years
• Histologically confirmed breast carcinoma (Stage 0-II) or high-risk lesions requiring excision
• Expected postoperative defect ≥20% of total breast volume
• ECOG 0-1, adequate organ function
• Informed consent provided, compliant with follow-up schedule

Exclusion Criteria:

• Prior breast surgery or radiotherapy to affected breast
• Locally advanced or inflammatory carcinoma
• Collagen hypersensitivity or autoimmune disease
• Active infection, pregnancy, lactation, or smoking within 6 weeks
• Concurrent participation in other clinical studies