Use of Dermal Matrix in Breast Reconstruction

Vanderbilt University

Status: Terminated

Conditions: Breast Cancer

Treatments: Procedure: DermaMatrix; Procedure: standard of care tissue expander breast reconstruction surgery after mastectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00692692

070416

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All women who are candidates for breast reconstruction using tissue expanders after mastectomy

Exclusion criteria

• Other forms of breast reconstruction after mastectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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36 participants in 2 patient groups

DermaMatrix

Experimental group

Description:

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

Treatment:

Procedure: DermaMatrix

Standard of care

Active Comparator group

Description:

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

Treatment:

Procedure: standard of care tissue expander breast reconstruction surgery after mastectomy