Clinical trial · Interventional
Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision
Regenerative High Purity Type I Collagen Scaffold for Breast Cancer Excision Repair and Reconstruction: A Prospective Multicenter Clinical Trial
NCT07219316CI-TRIAL-00106608completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast-Conserving Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Purity Type I Collagen Scaffold (Regenerative Matrix) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High Purity Type I Collagen Scaffold
- 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
- interventionNames
- Device: High Purity Type I Collagen Scaffold (Regenerative Matrix)
Primary outcomes (2)
- measure
- Volume Restoration
- timeFrame
- 2 months post-operative
- description
- Proportion of patients achieving ≥80% breast volume retention at 2 months assessed by imaging/MRI
- measure
- Patient Satisfaction With Breast Volume Restoration
- timeFrame
- 4 weeks and 8 weeks post-operative
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDNarayan 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
- BACKGROUNDNarayan 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
- BACKGROUNDvan 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
- BACKGROUNDSlavin 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
- BACKGROUNDNarayan 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