The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction

Vanderbilt University Medical Center

Status and phase: Terminated; Phase 4

Conditions: Postoperative Pain; Mastectomy; Complications

Treatments: Procedure: Serratus anterior to cover lateral aspect of tissue expander; Procedure: Dermamatrix to cover lateral aspect of tissue expander

Study type: Interventional

Funder types: Other

Identifiers

NCT00616824

070415

Details and patient eligibility

About

This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix as an inferolateral sling, instead of the muscle flap.

The study we are proposing will evaluate the question of whether there is a difference between the traditional method of serratus flap and the new technique of using an acellular matrix with tissue expander placement. This will be a double blinded randomized study of thirty women in each group comparing outcomes which will include postoperative pain, complications (wound infection, hematoma, capsular contracture, etc), and patient satisfaction with the procedure.

Enrollment: 36 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting to Dr. Wendel's clinic who are older than 17 years of age undergoing a mastectomy and wish to have breast reconstruction with a tissue expander or those who have previously undergone a mastectomy and are now seeking reconstruction will be solicited for the study.

Exclusion criteria

• Preoperative radiation therapy
• Autoimmune disease
• Fever
• Uncontrolled diabetes mellitus
• Inability to comprehend or cooperate with postoperative instructions
• Local or systemic infection
• Have any allergies to the excipient ingredients found in the matrix
• Pregnancy
• Low vascularity of the surrounding tissue
• Mechanical trauma
• Poor nutrition
• Poor general medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

Traditional Method

Active Comparator group

Description:

Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander

Treatment:

Procedure: Serratus anterior to cover lateral aspect of tissue expander

Dermamatrix Arm

Experimental group

Description:

Arm which uses Dermamatrix as the lateral expander coverage

Treatment:

Procedure: Dermamatrix to cover lateral aspect of tissue expander