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Use of Dermal Matrix in Breast Reconstruction

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ClinicalTrials.gov Identifier: NCT00692692
Recruitment Status : Terminated (higher rate of post-operative infection in the Dermal Matrix arm of the study)
First Posted : June 6, 2008
Results First Posted : October 11, 2013
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Vanderbilt University Medical Center ( Vanderbilt University )

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Procedure: DermaMatrix Procedure: standard of care tissue expander breast reconstruction surgery after mastectomy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : June 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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Arm Intervention/treatment
Experimental: DermaMatrix
experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
Procedure: DermaMatrix
experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
Other Name: tissue expander breast reconstruction after mastectomy

Active Comparator: Standard of care
standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
Procedure: standard of care tissue expander breast reconstruction surgery after mastectomy
standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
Other Name: standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix




Primary Outcome Measures :
  1. Patient Satisfaction With the Procedure [ Time Frame: one year from time of operation ]
  2. Post Surgical Infection [ Time Frame: 4 weeks ]
    Number of participants with post surgical infection



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center

Responsible Party: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00692692     History of Changes
Other Study ID Numbers: 070416
First Posted: June 6, 2008    Key Record Dates
Results First Posted: October 11, 2013
Last Update Posted: March 19, 2018
Last Verified: March 2018