Acellular Dermal Matrix in Breast Reconstruction (Adermbrerec)

University Hospital Bratislava

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Acellular dermal matrix implantation

Study type: Observational

Funder types: Other

Identifiers

NCT02835781

UHB/006/2015/MB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Acellular dermal matrix arm

Description:

The females undergoing breast reconstruction surgery after breast removal because of breast cancer. The breast reconstruction will be performed using acellular dermal matrix implantation.

Treatment:

Other: Acellular dermal matrix implantation