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

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Background Breast-conserving surgery (BCS) is the preferred treatment for early-stage breast cancer; however, excision-related volume loss frequently results in contour deformity, asymmetry, and reduced patient satisfaction. Conventional volume displacement and replacement techniques are limited by donor-site morbidity, technical complexity, and unpredictable aesthetic outcomes. High-purity type I collagen (HPTC) scaffolds represent a regenerative, biocompatible strategy designed to provide immediate volume support while promoting host tissue integration. Methods This prospective, single-arm, multicenter clinical trial was conducted at two tertiary care centers in India. Forty women undergoing BCS with an anticipated postoperative volume loss ≥20% received intraoperative implantation of an HPTC scaffold into the excision cavity. Patients were followed for two months. The primary outcome was breast volume restoration success, defined as ≥80% objective volume retention at two months with patient satisfaction ≥7/10. Secondary outcomes included objective volumetric analysis using MRI and three-dimensional surface imaging, radiologic integration assessed by the MRI Integration Score (MIS), cosmetic outcomes measured using the BREAST-Q, and safety. Longitudinal outcomes were analyzed using repeated-measures statistics, with effect sizes calculated to assess clinical relevance. Result

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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