Trials / Completed
CompletedNCT04209010
Immediate Breast Reconstruction With Acellular Dermal Matrix
Comparison of One-stage Direct-to-implant With Acellular Dermal Matrix and Two-stage Implant-based Breast Reconstruction: A Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 44 (actual)
- Sponsor
- Aarhus University Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Primary endpoint in first publication is postoperative complications, secondary endpoint is patient and investigator assessed aesthetic outcome. Primary endpoint in second publication is cost, secondary endpoint is patient reported outcome measures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | one-stage technique | breast reconstruction in one stage using silicone implant and acellular dermal matrix. |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2016-03-17
- Completion
- 2016-03-17
- First posted
- 2019-12-23
- Last updated
- 2020-01-03
Source: ClinicalTrials.gov record NCT04209010. Inclusion in this directory is not an endorsement.