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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00616824
First received: February 5, 2008
Last updated: February 14, 2008
Last verified: February 2008
History of Changes
  Purpose

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
Mastectomy
Postoperative Pain
Complications
 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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: perioperative up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • aesthetic outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • complications (infection, hematoma, capsular contracture) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Patient satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2007
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616824

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

No publications provided

Responsible Party: J. Jason Wendel, M.D., Vanderbilt University Department of Plastic Surgery
ClinicalTrials.gov Identifier: NCT00616824     History of Changes
Other Study ID Numbers: 070415, 070415
Study First Received: February 5, 2008
Last Updated: February 14, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013