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

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Status: Enrolling

Conditions: Breast-Conserving Surgery

Treatments: Device: High Purity Type I Collagen Scaffold (Regenerative Matrix)

Study type: Interventional

Funder types: Other

Identifiers

NCT07219316

AIMS/IEC/240/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

High Purity Type I Collagen Scaffold

Experimental group

Description:

Patients undergoing breast conservative surgery will receive immediate placement of high purity Type I collagen scaffold to fill tissue defect. The scaffold is a sterile, cross-linked bovine Type I collagen matrix with degradation time of 2 months, sterilized by ethylene oxide

Treatment:

Device: High Purity Type I Collagen Scaffold (Regenerative Matrix)