Try our beta test site

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

This study has been terminated.
Information provided by (Responsible Party):
Jason Wendel, Vanderbilt University Identifier:
First received: February 5, 2008
Last updated: August 3, 2013
Last verified: February 2008

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.

Condition Intervention Phase
Postoperative Pain
Procedure: Dermamatrix to cover lateral aspect of tissue expander
Procedure: Serratus anterior to cover lateral aspect of tissue expander
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: perioperative up to 1 year ]

Secondary Outcome Measures:
  • aesthetic outcome [ Time Frame: 1 year ]
  • complications (infection, hematoma, capsular contracture) [ Time Frame: 1 year ]
  • Patient satisfaction [ Time Frame: 1 year ]

Enrollment: 60
Study Start Date: September 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Dermamatrix


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00616824

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2345
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Jason J. Wendel, M.D. Vanderbilt University
  More Information

Responsible Party: Jason Wendel, Assistant Professor Plastic Surgery, Vanderbilt University Identifier: NCT00616824     History of Changes
Other Study ID Numbers: 070415
Study First Received: February 5, 2008
Last Updated: August 3, 2013

Keywords provided by Vanderbilt University:
Acellular dermal matrix
breast reconstruction
tissue expander
postoperative pain
patient satisfaction

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms processed this record on March 30, 2017