Clinical trial · Observational
Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction
Comparative Study of the Efficacy and Risk Profile of Two Animal-derived Acellular Dermal Matrices in Patients Undergoing Mastectomy, Radiotherapy and Implant-based Reconstruction
- 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)
The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the tissues of the patient and helps in contrasting the collateral effects of radiotherapy (capsular contracture, implant loss) The main questions the study aims to answer are: * is one of the two matrices better than the other? (better results with fewer complications) * is there a group of patients who benefit more than another from the use of this type of devices? * is there an adm which works better in one specific subgroup of patients? Participants have undergone mastectomy, radiotherapy and implant reconstruction with the aid of two different kinds of acellular dermal matrices. Researchers will compare patients who receive the porcine-derived adm and the patients who receive bovine-derived adm to see if there is a difference in terms of capsular contracture reduction, aestethic result and complications.
Conditions
Conditions (6)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Implant; Complications | — | UNRESOLVED | — |
| Breast Implant Infection | — | UNRESOLVED | — |
| Breast Implant Protrusion | — | UNRESOLVED | — |
| Breast Seroma | — | UNRESOLVED | — |
| Implant Capsular Contracture | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acellular dermal matrix implant for breast reconstruction | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- label
- POST QUART NATIVE
- description
- Native adm used in the setting of mastectomy and implant reconstruction after QUART
- interventionNames
- Device: acellular dermal matrix implant for breast reconstruction
- label
- POST QUART VERITAS
- description
- Veritas adm used in the setting of mastectomy and implant reconstruction after QUART
- interventionNames
- Device: acellular dermal matrix implant for breast reconstruction
- label
- POST EXPANDER NATIVE
- description
- Native adm used in the setting of expander removal and implant positioning after mastectomy + RT
- interventionNames
- Device: acellular dermal matrix implant for breast reconstruction
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * at least 6 months follow up * breast reconstruction with implant + acellular dermal matrix after mastectomy and radiotherapy Exclusion Criteria: * mastectomy flap \<1 cm * autoimmune disease * prolonged use of corticosteroids
References
Publications (0)
Data not yet available