Acellular Dermal Matrix in Breast Reconstruction

Completed

• Conditions: Breast Cancer
• Interventions: Other: Acellular dermal matrix implantation

• Registration Number: NCT02835781
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2014-01
• Study Completion: 2016-06
• Study First Submitted: 2016-06-28
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-13
• Last Update Submitted: 2016-07-13
• Study First Posted: 2016-07-18
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Bratislava; 🇸🇰 Bratislava, Slovakia