Expired Study
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Nashville, Tennessee 37232


Purpose:

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.


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


NCT ID:

NCT00616824


Primary Contact:

Principal Investigator
Jason J. Wendel, M.D.
Vanderbilt University


Backup Contact:

N/A


Location Contact:

Nashville, Tennessee 37232
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 17, 2018

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