Clinical trial · Observational
A Retrospective Breast Reconstruction Study
A Retrospective, Multi-Center, Open Label Study Evaluating SimpliDerm™ and Other Human Acellular Dermal Matrices in Breast Reconstruction
NCT04060134CI-TRIAL-00073998completedClinicalTrials.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)
To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AlloDerm HADM | Other | — | UNRESOLVED |
| AlloMax HADM | Other | — | UNRESOLVED |
| DermACELL HADM | Other | — | UNRESOLVED |
| FlexHD HADM | Other | — | UNRESOLVED |
| SimpliDerm HADM | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- SimpliDerm HADM
- description
- Patients who had SimpliDerm human acellular dermal matrix used in their breast reconstruction procedure.
- interventionNames
- Other: SimpliDerm HADM
- label
- AlloDerm HADM
- description
- Patients who had AlloDerm human acellular dermal matrix used in their breast reconstruction procedure.
- interventionNames
- Other: AlloDerm HADM
- label
- AlloMax HADM
- description
- Patients who had AlloMax human acellular dermal matrix used in their breast reconstruction procedure.
- interventionNames
- Other: AlloMax HADM
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Female patient who underwent immediate breast reconstruction post-mastectomy; either direct to implant or with a tissue expander followed by exchange for a saline or gel implant. * HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction. Exclusion Criteria: * Female patient who underwent cosmetic/aesthetic breast augmentation procedure or revision. * Female patient who underwent delayed breast reconstruction procedure. * Female patient who underwent revision of previous breast reconstruction procedure.
References
Publications (0)
Data not yet available
No reference posted for this study.