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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Standard breast-conserving surgery followed by immediate scaffold placement into the excision cavity. The scaffold is sutured using absorbable sutures and covered with standard wound closure. Postoperative care follows institutional protocols. Adjuvant radiotherapy and chemotherapy as indicated per oncological protocols; standard antibiotics and analgesics.
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, India
JSS Medical College Hospital
Mysore, Karnataka, India
Volume Restoration
Proportion of patients achieving ≥80% breast volume retention at 2 months assessed by imaging/MRI
Time frame: 2 months post-operative
Patient Satisfaction With Breast Volume Restoration
Patient satisfaction ≥7/10 on standardized satisfaction scale (BREAST-Q). The BREAST-Q is a validated patient-reported outcome measure (PROM) used to assess the quality of life and satisfaction of patients undergoing breast surgery. It consists of specific modules for different procedures, like reconstruction, and measures aspects such as psychological well-being, physical well-being (chest and sexual), and satisfaction with the breasts and care. The scale, which results in scores from 0 to 100, helps evaluate the impact of surgery from the patient's perspective. Scores range from 0 to 100, with higher scores indicating a greater degree of health-related quality of life or satisfaction.
Time frame: 4 weeks and 8 weeks post-operative
Objective Volume Assessment
Percentage change in breast volume at 2, 4, and 8 weeks post-surgery
Time frame: 2 weeks, 4 weeks, and 8 weeks post-operative
Cosmetic Assessment
Physician-rated 4-point cosmetic score. This is a standardized visual assessment tool used to evaluate the aesthetic outcome of the operated breast compared to the contralateral breast. The assessment is based on parameters such as breast shape, volume, symmetry, contour, nipple-areolar complex position, and scar appearance. The 4-point grading system is typically defined as: Grade 4 - Excellent - Described as operated breast almost identical to contralateral side - Criteria is minimal asymmetry, natural contour Grade 3 - Good - Described as slight difference in shape or volume - Acceptable symmetry and cosmetic result Grade 2 - Fair - Described as noticeable asymmetry or distortion - Moderate contour irregularity or scar visibility Grade 1 - Poor - Described as significant deformity or volume loss - Unacceptable cosmetic result
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Time frame: 2 months post-operative
Radiological Outcomes
MRI Scoring System - Scaffold Integration, Vascularization \& Resorption: Standardized MRI assessment of scaffold performance (integration, neovascularization, resorption) at baseline, Week 4, and Week 8. MRI protocol: T1 (axial/sagittal), T2/STIR (axial), DCE T1 (pre-contrast, early 30-60 s, intermediate 90-120 s, delayed 4-6 min), Scores (0-3 each): A. Integration: 0 = none; 1 = minimal; 2 = moderate; 3 = complete tissue continuity. B. Vascularization: 0 = none; 1 = mild/delayed; 2 = moderate (neovascular); 3 = marked (early enhancement). C. Resorption: 0 \> 75% residual; 1 = 50-75%; 2 = 25-50%; 3 \< 25% residual. D. Tissue Quality: 0 = fluid-filled; 1 = mostly fluid; 2 = mixed; 3 = tissue-like. Composite MRI Integration Score (MIS 0-12): Higher = better integration/remodeling. Interpretation: 0-3 Poor, 4-7 Moderate, 8-10 Good, 11-12 Excellent.
Time frame: Immediate postoperative, 4 weeks, and 8 weeks
Number of Participants With Postoperative Complications
Number of participants experiencing postoperative complications within the 2-month follow-up period after breast cancer excision and collagen scaffold implantation. Complications assessed include seroma, hematoma, surgical site infection, abscess, wound dehiscence, scaffold exposure or extrusion, prolonged postoperative pain, and ecchymosis. Each participant is counted once per complication category. Higher values indicate greater frequency of complications.
Time frame: 2 months