Acellular Dermal Matrix in Breast Reconstruction

Breast Cancer Clinical Trial

— Adermbrerec  

Official title:

Allogenic Acellular Dermal Matrix Use in Patients With Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835781
• Other study ID #: UHB/006/2015/MB
• Status: Completed
• Phase: N/A
• First received: June 28, 2016
• Last updated: July 13, 2016
• Start date: January 2010
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: University Hospital Bratislava
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Slovakia	University Hospital Bratislava	Bratislava

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Bratislava	Comenius University

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of complications in patients receiving acellular dermal matrix evaluated at 6 months after primary implantation	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.	6 months	Yes
Secondary	Histologic evaluation of ADM implants upon planned explantations	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	6 months	Yes
Secondary	Satisfaction with breast reconstruction outcome evaluated by Breast-Q questionnaire	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	2 years	No