Breast-Conserving Surgery
Conditions
Keywords
Breast-Conserving Surgery, Volume Restoration, Collagen Matrix, Breast Reconstruction, Regenerative Scaffold, High Purity Type I Collagen, Oncoplastic Surgery, Surgicoll-Mesh
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHigh Purity Type I Collagen Scaffold (Regenerative Matrix)
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.
Sponsors
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume Restoration | 2 months post-operative | Proportion of patients achieving ≥80% breast volume retention at 2 months assessed by imaging/MRI |
| Patient Satisfaction With Breast Volume Restoration | 4 weeks and 8 weeks post-operative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Volume Assessment | 2 weeks, 4 weeks, and 8 weeks post-operative | Percentage change in breast volume at 2, 4, and 8 weeks post-surgery |
| Cosmetic Assessment | 2 months post-operative | 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 |
| Radiological Outcomes | Immediate postoperative, 4 weeks, and 8 weeks | 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. |
| Number of Participants With Postoperative Complications | 2 months | 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. |
Countries
India
Contacts
STUDY_CHAIRPrema Dhanraj, MS, MCh
Rajarajeswari Medical College and Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 49.6 years STANDARD_DEVIATION 8.9 |
| Body Mass Index (BMI) | 24.8 kg/m² STANDARD_DEVIATION 3.6 |
| ECOG Performance Status ECOG 0 | 28 Participants |
| ECOG Performance Status ECOG 1 | 12 Participants |
| Histopathology Ductal carcinoma in situ | 8 Participants |
| Histopathology High-risk benign/premalignant | 4 Participants |
| Histopathology Invasive ductal carcinoma | 28 Participants |
| Race/Ethnicity, Customized Asian (Indian) | 40 Participants |
| Region of Enrollment India | 40 participants |
| Sex/Gender, Customized Female | 40 Participants |
| Tumor Location Lower inner quadrant | 2 Participants |
| Tumor Location Lower outer quadrant | 5 Participants |
| Tumor Location Upper inner quadrant | 8 Participants |
| Tumor Location Upper outer quadrant | 25 Participants |
| Tumor Stage Stage 0 | 8 Participants |
| Tumor Stage Stage I | 22 Participants |
| Tumor Stage Stage II | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 6 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
None listed