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

Abstract

<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>All 40 enrolled patients completed the two-month follow-up. The composite primary endpoint (≥80% volume retention plus patient satisfaction ≥7/10) was achieved in 82.5% of patients (33/40). Mean breast volume retention at two months was 88.6% ± 9.8%, significantly exceeding the predefined benchmark of 75% (p < 0.001; Cohen's d = 1.39). MIS demonstrated progressive scaffold integration, improving from 3.2 ± 1.1 postoperatively to 9.1 ± 1.4 at eight weeks (p < 0.001; Cohen's d = 2.8), with no suspicious imaging features. BREAST-Q "Satisfaction with Breasts" scores improved by 24.7 points from baseline (54.2 ± 8.6 to 78.9 ± 7.4; p < 0.001; Cohen's d = 1.8). No device-related serious adverse events occurred; minor complications (seroma 10%, infection 5%) resolved with conservative management.<h4>Conclusion</h4>HPTC scaffold implantation following BCS demonstrates excellent safety, robust early volume restoration (88.6% retention at two months), progressive biological integration, and clinically meaningful improvement in patient satisfaction. This minimally invasive regenerative approach avoids donor-site morbidity while achieving outcomes comparable to traditional oncoplastic techniques, warranting evaluation in randomized controlled trials with longer follow-up to assess durability and radiotherapy response.