Acellular Dermal Matrix in Breast Reconstruction

NCT02835781 | Completed

• 1 other identifier: UHB/006/2015/MB
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Implants; Acellular Dermal Matrix

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Histologic evaluation of ADM implants upon planned explantations

  6 months

• Satisfaction with breast reconstruction outcome evaluated by Breast-Q questionnaire

  2 years

Study Arms (1)

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

Interventions

Acellular dermal matrix implantation OTHER

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

Also known as: breast reconstruction

Acellular dermal matrix arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• signed informed consent
• total one-side mastectomy due to breast cancer
• age between 18-60 years

You may not qualify if:

• failure to obtain signed informed consent

Sponsors & Collaborators

• University Hospital Bratislava: lead
• Comenius University: collaborator

Study Sites (1)

University Hospital Bratislava

Bratislava, 82101, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 28812172 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Acellular dermal tissue after primary reconstruction will be harvested prior to second surgery with permanent implant.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammaplasty

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Miroslav Bdzoch, MD, PhD

  University Hospital Bratislava, Pazitkova 4, Bratislava, Slovakia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 18, 2016
• Study Start: January 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2016
• Last Updated: July 18, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)