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

The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction After Mastectomy: A Double-Blinded, Randomized Trial

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain; Complications; Mastectomy
• Intervention / Treatment: Procedure: Serratus anterior to cover lateral aspect of tissue expander; Procedure: Dermamatrix to cover lateral aspect of tissue expander

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-2345
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional Method; Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander	Procedure: Serratus anterior to cover lateral aspect of tissue expander; Traditional use of serratus anterior for coverage of lateral aspect of tissue expander
Experimental: Dermamatrix Arm; Arm which uses Dermamatrix as the lateral expander coverage	Procedure: Dermamatrix to cover lateral aspect of tissue expander; Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy; Other Names: Dermamatrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
postoperative pain	perioperative up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
aesthetic outcome	1 year
complications (infection, hematoma, capsular contracture)	1 year
Patient satisfaction	1 year

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Jason J. Wendel, M.D., Vanderbilt University

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: February 5, 2008
• First Submitted That Met QC Criteria: February 14, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: pain; postoperative pain; patient satisfaction; breast reconstruction; complication; tissue expander; Acellular dermal matrix
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 070415