---
title: Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision
nct_id: NCT07219316
overall_status: COMPLETED
phase: NA
sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara
study_type: INTERVENTIONAL
primary_condition: Breast-Conserving Surgery
countries: India
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07219316.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07219316"
ct_last_update_post_date: 2026-03-27
last_seen_at: "2026-05-12T07:28:01.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision

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

**NCT ID:** [NCT07219316](https://clinicaltrials.gov/study/NCT07219316)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Adichunchanagiri Institute of Medical Sciences, B G Nagara
- **Conditions:** Breast-Conserving Surgery
- **Start Date:** 2025-10-15
- **Completion Date:** 2026-02-25
- **CT.gov Last Update:** 2026-03-27

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** FEMALE
- **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
```

## Arms

- **High Purity Type I Collagen Scaffold** (EXPERIMENTAL) — 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

## 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.

## Primary Outcomes

- **Volume Restoration** _(time frame: 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** _(time frame: 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 Outcomes

- **Objective Volume Assessment** _(time frame: 2 weeks, 4 weeks, and 8 weeks post-operative)_
- **Cosmetic Assessment** _(time frame: 2 months post-operative)_
- **Radiological Outcomes** _(time frame: Immediate postoperative, 4 weeks, and 8 weeks)_
- **Number of Participants With Postoperative Complications** _(time frame: 2 months)_

## Locations (2)

- Adichunchanagiri Institute of Medical Sciences, Mandya, Karnataka, India
- JSS Medical College Hospital, Mysore, Karnataka, India

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.adichunchanagiri institute of medical sciences|mandya|karnataka|india` — added _(2026-05-12)_
- `locations.jss medical college hospital|mysore|karnataka|india` — added _(2026-05-12)_

---

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