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

NCT ID: NCT00616824

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-03-31

Brief Summary

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.

Conditions

Mastectomy; Postoperative Pain; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Traditional Method

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

Group Type: ACTIVE_COMPARATOR

Serratus anterior to cover lateral aspect of tissue expander

Intervention Type: PROCEDURE

Traditional use of serratus anterior for coverage of lateral aspect of tissue expander

Dermamatrix Arm

Arm which uses Dermamatrix as the lateral expander coverage

Group Type: EXPERIMENTAL

Dermamatrix to cover lateral aspect of tissue expander

Intervention Type: PROCEDURE

Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy

Interventions

Dermamatrix to cover lateral aspect of tissue expander

Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy

Intervention Type: PROCEDURE

Serratus anterior to cover lateral aspect of tissue expander

Traditional use of serratus anterior for coverage of lateral aspect of tissue expander

Intervention Type: PROCEDURE

Other Intervention Names

Dermamatrix

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason J. Wendel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

070415

Identifier Type: -

Identifier Source: secondary_id

070415

Identifier Type: -

Identifier Source: org_study_id