Trial Outcomes & Findings for Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision (NCT NCT07219316)
NCT ID: NCT07219316
Last Updated: 2026-03-27
Results Overview
Proportion of patients achieving ≥80% breast volume retention at 2 months assessed by imaging/MRI
COMPLETED
NA
40 participants
2 months post-operative
2026-03-27
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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40
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision
Baseline characteristics by cohort
| Measure |
High Purity Type I Collagen Scaffold
n=40 Participants
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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Age, Categorical
<=18 years
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0 Participants
n=56 Participants
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Age, Categorical
Between 18 and 65 years
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40 Participants
n=56 Participants
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Age, Categorical
>=65 years
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0 Participants
n=56 Participants
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Age, Continuous
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49.6 years
STANDARD_DEVIATION 8.9 • n=56 Participants
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Sex/Gender, Customized
Female
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40 Participants
n=56 Participants
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Race/Ethnicity, Customized
Asian (Indian)
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40 Participants
n=56 Participants
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Region of Enrollment
India
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40 participants
n=56 Participants
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Body Mass Index (BMI)
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24.8 kg/m²
STANDARD_DEVIATION 3.6 • n=56 Participants
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ECOG Performance Status
ECOG 0
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28 Participants
n=56 Participants
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ECOG Performance Status
ECOG 1
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12 Participants
n=56 Participants
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Histopathology
Invasive ductal carcinoma
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28 Participants
n=56 Participants
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Histopathology
Ductal carcinoma in situ
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8 Participants
n=56 Participants
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Histopathology
High-risk benign/premalignant
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4 Participants
n=56 Participants
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Tumor Stage
Stage 0
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8 Participants
n=56 Participants
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Tumor Stage
Stage I
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22 Participants
n=56 Participants
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Tumor Stage
Stage II
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10 Participants
n=56 Participants
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Tumor Location
Upper outer quadrant
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25 Participants
n=56 Participants
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Tumor Location
Upper inner quadrant
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8 Participants
n=56 Participants
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Tumor Location
Lower outer quadrant
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5 Participants
n=56 Participants
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Tumor Location
Lower inner quadrant
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2 Participants
n=56 Participants
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PRIMARY outcome
Timeframe: 2 months post-operativeProportion of patients achieving ≥80% breast volume retention at 2 months assessed by imaging/MRI
Outcome measures
| Measure |
High Purity Type I Collagen Scaffold
n=40 Participants
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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|---|---|
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Volume Restoration
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33 Participants
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PRIMARY outcome
Timeframe: 4 weeks and 8 weeks post-operativePatient 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.
Outcome measures
| Measure |
High Purity Type I Collagen Scaffold
n=40 Participants
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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Patient Satisfaction With Breast Volume Restoration
4 weeks
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72.5 score on a scale
Standard Deviation 7.9
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Patient Satisfaction With Breast Volume Restoration
8 weeks
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78.9 score on a scale
Standard Deviation 7.4
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SECONDARY outcome
Timeframe: 2 weeks, 4 weeks, and 8 weeks post-operativePercentage change in breast volume at 2, 4, and 8 weeks post-surgery
Outcome measures
| Measure |
High Purity Type I Collagen Scaffold
n=40 Participants
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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Objective Volume Assessment
8 weeks
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88.6 Percentage change in breast volume
Standard Deviation 9.8
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Objective Volume Assessment
2 weeks
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92.4 Percentage change in breast volume
Standard Deviation 7.1
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Objective Volume Assessment
4 weeks
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90.1 Percentage change in breast volume
Standard Deviation 8.6
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SECONDARY outcome
Timeframe: 2 months post-operativePhysician-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
Outcome measures
| Measure |
High Purity Type I Collagen Scaffold
n=40 Participants
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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Cosmetic Assessment
Poor
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0 Participants
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Cosmetic Assessment
Excellent
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22 Participants
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Cosmetic Assessment
Good
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14 Participants
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Cosmetic Assessment
Fair
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4 Participants
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SECONDARY outcome
Timeframe: Immediate postoperative, 4 weeks, and 8 weeksMRI 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.
Outcome measures
| Measure |
High Purity Type I Collagen Scaffold
n=40 Participants
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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Radiological Outcomes
Immediate postoperative
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3.2 score on a scale
Standard Deviation 1.1
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Radiological Outcomes
4 weeks
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6.8 score on a scale
Standard Deviation 1.3
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Radiological Outcomes
8 weeks
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9.1 score on a scale
Standard Deviation 1.4
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SECONDARY outcome
Timeframe: 2 monthsNumber 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.
Outcome measures
| Measure |
High Purity Type I Collagen Scaffold
n=40 Participants
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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Number of Participants With Postoperative Complications
Ecchymosis
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3 Participants
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Number of Participants With Postoperative Complications
Seroma
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4 Participants
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Number of Participants With Postoperative Complications
Superficial surgical site infection
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2 Participants
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Number of Participants With Postoperative Complications
Prolonged postoperative pain
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6 Participants
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Adverse Events
High Purity Type I Collagen Scaffold
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Purity Type I Collagen Scaffold
n=40 participants at risk
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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Blood and lymphatic system disorders
Seroma
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10.0%
4/40 • Number of events 4 • 2 months
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Surgical and medical procedures
Superficial surgical site infection
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5.0%
2/40 • Number of events 2 • 2 months
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Additional Information
Prof Naveen Narayan
Adichunchanagiri Institute of Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place