Use of Dermal Matrix in Breast Reconstruction

This study has been terminated.
(higher rate of post-operative infectin in the Dermal Matrix arm of the study)
Sponsor:
Information provided by (Responsible Party):
Jason Wendel, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00692692
First received: June 4, 2008
Last updated: August 3, 2013
Last verified: July 2013
  Purpose

We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.


Condition Intervention
Breast Cancer
Procedure: DermaMatrix
Procedure: standard of care tissue expander breast reconstruction surgery after mastectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of An Acellular Dermal Matrix Sling in a Two-stage Breast REconstruciton After Mastectomy: A Double-blinded Randomized Trial

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Patient Satisfaction With the Procedure [ Time Frame: one year from time of operation ] [ Designated as safety issue: No ]
  • Post-surgical Infeciton [ Time Frame: four weekis ] [ Designated as safety issue: Yes ]
    Occurence of infection after surgery


Enrollment: 36
Study Start Date: June 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
experimental group with DermaMatrix acellular dermis over tissue expanders in addition to muscle and skin to allow for more natural appearing breast and prevention of complications
Procedure: DermaMatrix
DermaMatrix acellular dermis with tissue expanders after mastectomy for breast reconstruction
Other Name: tissue expander breast reconstruction after mastectomy
Active Comparator: muscle over tissue expander
standard of care muscle coverage of tissue expander for breast reconstruction after mastectomy
Procedure: DermaMatrix
DermaMatrix acellular dermis with tissue expanders after mastectomy for breast reconstruction
Other Name: tissue expander breast reconstruction after mastectomy
Procedure: standard of care tissue expander breast reconstruction surgery after mastectomy
standard of care muscle coverage over Tissue expander for breast reconstruction
Other Name: standard of care muscle coverage over tissue expander for breast reconstruction surgery after mastectomy

Detailed Description:

We propose a double blinded, randomized study of 60 women comparing outcomes which will include postoperative pain, complication rates and aesthetic outcome as assessed by the patient and a plastic surgeon blinded to the method of reconstruction.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All women who are candidates for breast reconstruction using tissue expanders after mastectomy

Exclusion Criteria:

  • Other forms of breast reconstruction after mastectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692692

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Jason Wendel, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Jason Wendel, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00692692     History of Changes
Other Study ID Numbers: 070416
Study First Received: June 4, 2008
Results First Received: August 3, 2013
Last Updated: August 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014