Clinical trial · Observational
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
- 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 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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acellular Dermis | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Carcinoma in Situ | Breast Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Mammaplasty | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| one-stage technique | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- One-stage group
- description
- Immediate implant based breast reconstruction after skin sparing mastectomy in one stage using silicone implant and acellular dermal matrix.
- interventionNames
- Procedure: one-stage technique
- label
- Two-stage group
- description
- Immediate implant based breast reconstruction after skin sparing mastectomy in two stages using expander to silicone implant technique.
Primary outcomes (2)
- measure
- Postoperative complications
- timeFrame
- 3 months
- description
- Major (requiring surgery - infection, hematoma, mastectomy flap necrosis). Obtained by review of patient chart.
- measure
- Postoperative complications
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Skin sparing mastectomy due to breast cancer, ductal carcinoma in situ or high genetic risk of developing breast cancer * Mastectomy weight ≤ 600 g * Patient older than 18 years * Ability to complete the study questionnaire * Only for the two-stage group no later than 2 years and 4 months from breast reconstruction Exclusion Criteria: \- smokers
References
Publications (1)
- DERIVEDBrunbjerg ME, Jensen TB, Overgaard J, Christiansen P, Damsgaard TE. Comparison of one-stage direct-to-implant with acellular dermal matrix and two-stage immediate implant-based breast reconstruction-a cohort study. Gland Surg. 2021 Jan;10(1):207-218. doi: 10.21037/gs-20-581. PMID 33633977