Acellular Dermal Matrix in Breast Reconstruction (Adermbrerec)
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|ClinicalTrials.gov Identifier: NCT02835781|
Recruitment Status : Completed
First Posted : July 18, 2016
Last Update Posted : July 18, 2016
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: Acellular dermal matrix implantation|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Allogenic Acellular Dermal Matrix Use in Patients With Breast Reconstruction|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||June 2016|
Acellular dermal matrix arm
The females undergoing breast reconstruction surgery after breast removal because of breast cancer. The breast reconstruction will be performed using acellular dermal matrix implantation.
Other: Acellular dermal matrix implantation
Acellular dermal matrix obtained from Central tissue bank, University Hospital Bratislava, will be used for acellular dermal matrix implantation.
Other Name: breast reconstruction
- Number of complications in patients receiving acellular dermal matrix evaluated at 6 months after primary implantation [ Time Frame: 6 months ]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.
- Histologic evaluation of ADM implants upon planned explantations [ Time Frame: 6 months ]All patients between January 2012 and June 2014 after primary ADM transplantation will be evaluated. Analysis of cell composition, leukocytes at place, vessel formation and dysplasias will be performed
- Satisfaction with breast reconstruction outcome evaluated by Breast-Q questionnaire [ Time Frame: 2 years ]Physical and psychical as well as sexual well-being with outcome will be evaluated by specifically for this purpose developed questionnaire (The Breast-Q questionnaire) after permanent breast implant implantation at 2 years
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835781
|University Hospital Bratislava|
|Bratislava, Slovakia, 82101|
|Study Director:||Miroslav Bdzoch, MD, PhD||University Hospital Bratislava, Pazitkova 4, Bratislava, Slovakia|