Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision

NCT07219316 | Completed Results FDA Device

• 1 other identifier: AIMS/IEC/240/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast-Conserving Surgery

Keywords

Breast-Conserving Surgery; Volume Restoration; Collagen Matrix; Breast Reconstruction; Regenerative Scaffold; High Purity Type I Collagen; Oncoplastic Surgery; Surgicoll-Mesh

Outcome Measures

Primary Outcomes (2)

• Volume Restoration

  Proportion of patients achieving ≥80% breast volume retention at 2 months assessed by imaging/MRI

  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.

  4 weeks and 8 weeks post-operative

Secondary Outcomes (4)

• Objective Volume Assessment

  2 weeks, 4 weeks, and 8 weeks post-operative

• Cosmetic Assessment

  2 months post-operative

• Radiological Outcomes

  Immediate postoperative, 4 weeks, and 8 weeks

• Number of Participants With Postoperative Complications

  2 months

Study Arms (1)

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

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

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.

High Purity Type I Collagen Scaffold

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adichunchanagiri Institute of Medical Sciences, B G Nagara: lead

Study Sites (2)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, 571448, India

Location

JSS Medical College Hospital

Mysore, Karnataka, 570004, India

Location

Related Publications (5)

• Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.

  PMID: 40747200 BACKGROUND

• Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec.

  PMID: 39649230 BACKGROUND

• van Loevezijn AA, Geluk CS, van den Berg MJ, van Werkhoven ED, Vrancken Peeters MTFD, van Duijnhoven FH, Hoornweg MJ. Immediate or delayed oncoplastic surgery after breast conserving surgery at the Netherlands Cancer Institute: a cohort study of 251 cases. Breast Cancer Res Treat. 2023 Apr;198(2):295-307. doi: 10.1007/s10549-022-06841-8. Epub 2023 Jan 24.

  PMID: 36690822 BACKGROUND

• Slavin SA, Halperin T. Reconstruction of the breast conservation deformity. Semin Plast Surg. 2004 May;18(2):89-96. doi: 10.1055/s-2004-829043.

  PMID: 20574487 BACKGROUND

• Narayan N, Ramegowda YH, Raghupathi DS, Chethan S, Gowda S. Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane. Cureus. 2025 Aug 25;17(8):e90956. doi: 10.7759/cureus.90956. eCollection 2025 Aug.

  PMID: 40862036 BACKGROUND

Limitations and Caveats

Single-arm design without a concurrent control group limits causal inference and prevents direct statistical comparison with alternative reconstruction techniques Short follow-up duration Study population was relatively homogeneous, consisting of women with early-stage disease (stage 0-II)

Results Point of Contact

• Title: Prof Naveen Narayan
• Organization: Adichunchanagiri Institute of Medical Sciences

naveen_uno1@yahoo.co.in

+91-9980023372

Study Officials

• Prema Dhanraj, MS, MCh

  Rajarajeswari Medical College and Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 21, 2025
• Study Start: October 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 25, 2026
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months post-publication
• Access Criteria: Researchers providing methodologically sound proposals with IRB approval

Locations

IN (2)