Clinical trial · Observational
Acellular Dermal Matrix in Breast Reconstruction
Allogenic Acellular Dermal Matrix Use in Patients With Breast Reconstruction
NCT02835781CI-TRIAL-00023119AdermbrereccompletedClinicalTrials.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)
Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls reconstructions. However, it is solely used in breast reconstructions after breast carcinoma amputation. The efficacy of such allogenic dermal matrix can be advantageous when compared to current treatment options, however, this has to be proved.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acellular dermal matrix implantation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Acellular dermal matrix arm
- description
- The females undergoing breast reconstruction surgery after breast removal because of breast cancer. The breast reconstruction will be performed using acellular dermal matrix implantation.
- interventionNames
- Other: Acellular dermal matrix implantation
Primary outcomes (1)
- measure
- Number of complications in patients receiving acellular dermal matrix evaluated at 6 months after primary implantation
- timeFrame
- 6 months
- description
- All patients between January 2010 and June 2014 undergoing primary ADM implantation will be evaluated at 6 months after implantation for early ex-plantations, inflammation, deformities of the implants, allergic reactions will be observed in patients undergoing primary ADM implantation at 6 months until second permanent implantation is performed.
Secondary outcomes (2)
- measure
- Histologic evaluation of ADM implants upon planned explantations
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * signed informed consent * total one-side mastectomy due to breast cancer * age between 18-60 years Exclusion Criteria: * failure to obtain signed informed consent
References
Publications (1)
- DERIVEDBohac M, Varga I, Polak S, Dragunova J, Fedeles J Sr, Koller J. Delayed post mastectomy breast reconstructions with allogeneic acellular dermal matrix prepared by a new decellularizationmethod. Cell Tissue Bank. 2018 Mar;19(1):61-68. doi: 10.1007/s10561-017-9655-0. Epub 2017 Aug 16. PMID 28812172