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OpenTrials
Completed

NCT Number: NCT02835781

Acellular Dermal Matrix in Breast Reconstruction

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Bratislava

Bratislava, 82101, Slovakia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acellular dermal matrix implantation

Other

Acellular dermal matrix obtained from Central tissue bank, University Hospital Bratislava, will be used for acellular dermal matrix implantation.

Other names: breast reconstruction

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital Bratislava

Other

Collaborators

  • Comenius University

Registry information

Official study title

Allogenic Acellular Dermal Matrix Use in Patients With Breast Reconstruction

Acronym: Adermbrerec

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
Jul 18, 2016
Registry last updated
Jul 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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