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
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 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 August 28, 2014