Clinical trial · Observational
Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12
Objective Evaluation of Collagen Deposition in AlloMaxTM Acellular Dermal Matrix in Breast Reconstruction Version 8-15-12
NCT01679223CI-TRIAL-00016571unknownClinicalTrials.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)
The purpose of this study is to measure the level of AlloMax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction. The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast capsule at the 3-4 month time point.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- <40 years
- description
- subjects aged less than 40 years
- label
- 40-60 years
- description
- subjects aged 40-60years
- label
- > 60 years
- description
- subjects aged greater than 60 years
Primary outcomes (3)
- measure
- Hydroxyproline Concentration
- timeFrame
- 3-4 months
- description
- Hydroxyproline will be measured in the AlloMaxTM and adjacent capsule.
- measure
- Neoangiogenesis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (18 - 70 yrs) who require reconstructive breast surgery with AlloMaxTM implants and agree to participate will be included in this study. Exclusion Criteria: * Patients who do not agree to be included in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.