Acellular Dermal Matrix in Breast Reconstruction

NCT ID: NCT02835781

Last Updated: 2016-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Acellular dermal matrix implantation

Intervention Type OTHER

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

Interventions

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Acellular dermal matrix implantation

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

Intervention Type OTHER

Other Intervention Names

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breast reconstruction

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Comenius University

OTHER

Sponsor Role collaborator

University Hospital Bratislava

OTHER

Sponsor Role lead

Responsible Party

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Julius Hodosy

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miroslav Bdzoch, MD, PhD

Role: STUDY_DIRECTOR

University Hospital Bratislava, Pazitkova 4, Bratislava, Slovakia

Locations

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University Hospital Bratislava

Bratislava, , Slovakia

Site Status

Countries

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Slovakia

References

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Bohac 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.

Reference Type DERIVED
PMID: 28812172 (View on PubMed)

Other Identifiers

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UHB/006/2015/MB

Identifier Type: -

Identifier Source: org_study_id

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