Use of Dermal Matrix in Breast Reconstruction

Vanderbilt University36 enrolled

Overview

We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.

We propose a double blinded, randomized study of 60 women comparing outcomes which will include postoperative pain, complication rates and aesthetic outcome as assessed by the patient and a plastic surgeon blinded to the method of reconstruction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Breast Cancer

Interventions

DermaMatrixPROCEDURE

experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications

standard of care tissue expander breast reconstruction surgery after mastectomyPROCEDURE

standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All women who are candidates for breast reconstruction using tissue expanders after mastectomy Exclusion Criteria: * Other forms of breast reconstruction after mastectomy

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Patient Satisfaction With the Procedure

Time frame: one year from time of operation

Post Surgical Infection

Number of participants with post surgical infection

Time frame: 4 weeks

Data from ClinicalTrials.gov

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