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Trial record 18 of 1644 for:    Slovakia

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
Sponsor:
Collaborator:
Comenius University
Information provided by (Responsible Party):
Julius Hodosy, University Hospital Bratislava

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.

Condition or disease Intervention/treatment
Breast Cancer Other: Acellular dermal matrix implantation

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Acellular dermal tissue after primary reconstruction will be harvested prior to second surgery with permanent implant.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The cohort will be selected from patients with breast cancer and in remission, sent to plastic and reconstruction surgery clinics for breast reconstruction after therapeutical mastectomy.
Criteria

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

Information from the National Library of Medicine

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


Locations
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Slovakia
University Hospital Bratislava
Bratislava, Slovakia, 82101
Sponsors and Collaborators
University Hospital Bratislava
Comenius University
Investigators
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Study Director: Miroslav Bdzoch, MD, PhD University Hospital Bratislava, Pazitkova 4, Bratislava, Slovakia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julius Hodosy, Principal investigator, University Hospital Bratislava
ClinicalTrials.gov Identifier: NCT02835781     History of Changes
Other Study ID Numbers: UHB/006/2015/MB
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Julius Hodosy, University Hospital Bratislava:
Breast Implants
Acellular Dermal Matrix