Breast Cancer
Conditions
Keywords
Breast Implants, Acellular Dermal Matrix
Brief summary
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.
Detailed description
This is a prospective study, where patients undergoing breast reconstruction surgery using acellular dermal matrix (ADM) with expander use in first phase of reconstruction will be included. The permanent breast implants will be implanted approximately half year during second surgery. Acellular dermal matrix is a soft tissue graft that is formed by decellularization, however with intact extracellular dermal matrix. Such structure is able to re-create adequate skeleton for host cells with subsequent incorporation and revascularization. The safety and appropriateness of such ADM in breast reconstruction surgery will be analyzed.
Interventions
OTHERAcellular dermal matrix implantation
Acellular dermal matrix obtained from Central tissue bank, University Hospital Bratislava, will be used for acellular dermal matrix implantation.
Sponsors
Comenius University
University Hospital Bratislava
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of complications in patients receiving acellular dermal matrix evaluated at 6 months after primary implantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histologic evaluation of ADM implants upon planned explantations | 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 | 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 |
Countries
Slovakia
Outcome results
None listed