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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Volume Assessment | Percentage change in breast volume at 2, 4, and 8 weeks post-surgery | 2 weeks, 4 weeks, and 8 weeks 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prema Dhanraj, MS, MCh | Rajarajeswari Medical College and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adichunchanagiri Institute of Medical Sciences | Mandya | Karnataka | 571448 | India | ||
| JSS Medical College Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40747200 | Background | 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. | |
| 39649230 |
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De-identified datasets will be available upon reasonable request following publication of primary results.
Beginning 6 months post-publication
Researchers providing methodologically sound proposals with IRB approval
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| ID | Title | Description |
|---|---|---|
| FG000 | High Purity Type I Collagen Scaffold | 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. Participants, not individual breasts, were the unit of assignment. Each participant underwent breast cancer excision with a single corresponding defect and received one collagen scaffold implantation. Therefore, outcomes are reported per participant without double counting. High 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Purity Type I Collagen Scaffold | 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 High 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Volume Restoration | Proportion of patients achieving ≥80% breast volume retention at 2 months assessed by imaging/MRI | Posted | Count of Participants | Participants | 2 months post-operative |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Purity Type I Collagen Scaffold | 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 High 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Blood and lymphatic system disorders | Non-systematic Assessment |
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)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Naveen Narayan | Adichunchanagiri Institute of Medical Sciences | +91-9980023372 | naveen_uno1@yahoo.co.in |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2026 | Mar 5, 2026 | Prot_SAP_000.pdf |
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|
| 2 months post-operative |
| Radiological Outcomes | 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. | Immediate postoperative, 4 weeks, and 8 weeks |
| Number of Participants With Postoperative Complications | 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. | 2 months |
| Mysore |
| Karnataka |
| 570004 |
| India |
| 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. |
| 36690822 | 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. |
| 20574487 | 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. |
| 40862036 | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Sex of participants enrolled in the study. Breast cancer surgery trials typically enroll female patients; therefore, all participants in this study were women undergoing breast-conserving surgery with collagen scaffold implantation. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
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| ECOG Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status is a standardized scale used to assess the functional status of cancer patients and their ability to perform daily activities. Scores range from 0 to 5, where 0 indicates fully active without restriction and higher scores indicate increasing levels of disability. In this study, eligible participants had ECOG performance status of 0 or 1. | Count of Participants | Participants |
|
| Histopathology | Count of Participants | Participants |
|
| Tumor Stage | Tumor stage was classified according to the American Joint Committee on Cancer (AJCC) TNM staging system (8th edition), based on tumor size (T), nodal involvement (N), and absence of distant metastasis (M). Stage 0: Carcinoma in situ (non-invasive disease). Stage I: Early-stage invasive cancer confined to the breast with small tumor size and no or minimal nodal involvement. Stage II: Larger tumor and/or limited regional lymph node involvement without distant metastasis. Higher stage indicates more advanced disease and greater tumor burden. | Count of Participants | Participants |
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| Tumor Location | Count of Participants | Participants |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks and 8 weeks post-operative |
|
|
|
| Secondary | Objective Volume Assessment | Percentage change in breast volume at 2, 4, and 8 weeks post-surgery | Posted | Mean | Standard Deviation | Percentage change in breast volume | 2 weeks, 4 weeks, and 8 weeks post-operative |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 2 months post-operative |
|
|
|
| Secondary | Radiological Outcomes | 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. | Posted | Mean | Standard Deviation | score on a scale | Immediate postoperative, 4 weeks, and 8 weeks |
|
|
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| Secondary | Number of Participants With Postoperative Complications | 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. | Posted | Count of Participants | Participants | 2 months |
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| 0 |
| 40 |
| 0 |
| 40 |
| 6 |
| 40 |
| Superficial surgical site infection | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
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| Poor |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Ecchymosis |
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