Regenerative Collagen Scaffold for Breast Volume Restoration in Breast-Conserving Surgery

N/ARecruitingNCT07219316

Adichunchanagiri Institute of Medical Sciences, B G Nagara40 enrolled

Overview

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

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast-Conserving Surgery

Interventions

High Purity Type I Collagen Scaffold (Regenerative Matrix)DEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, India

RECRUITING

JSS Medical College Hospital

Mysore, Karnataka, India

RECRUITING

Outcomes

Primary Outcomes

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: 2 months post-operative

Secondary Outcomes

Objective Volume Assessment

Percentage change in breast volume at 2, 4, and 8 weeks post-surgery

Time frame: 2 months post-operative

Breast Volume symmetry index

Volume symmetry index - operated vs. contralateral breast. The Breast Volume Symmetry Index (BVSI) quantifies postoperative symmetry between the operated and contralateral (unoperated) breasts. It is calculated as the ratio of the breast volume on the operated side to that of the contralateral side, multiplied by 100 to express as a percentage: BVSI = (Operated Breast Volume / Contralateral Breast Volume) × 100. A value of 100% indicates perfect symmetry, while lower values indicate volume deficit.

Time frame: 2 months 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

Central Contacts

Naveen Narayan, MS, MCh

CONTACT

+919980023372 naveen_uno1@yahoo.co.in

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.