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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Jason Wendel, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00616824
First received: February 5, 2008
Last updated: August 3, 2013
Last verified: February 2008

February 5, 2008
August 3, 2013
September 2007
September 2013   (final data collection date for primary outcome measure)
postoperative pain [ Time Frame: perioperative up to 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00616824 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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 The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction After Mastectomy: A Double-Blinded, Randomized Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Mastectomy
  • Postoperative Pain
  • Complications
  • Procedure: Dermamatrix to cover lateral aspect of tissue expander
    Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy
    Other Name: Dermamatrix
  • Procedure: Serratus anterior to cover lateral aspect of tissue expander
    Traditional use of serratus anterior for coverage of lateral aspect of tissue expander
  • Active Comparator: Traditional Method
    Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander
    Intervention: Procedure: Serratus anterior to cover lateral aspect of tissue expander
  • Experimental: Dermamatrix Arm
    Arm which uses Dermamatrix as the lateral expander coverage
    Intervention: Procedure: Dermamatrix to cover lateral aspect of tissue expander
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00616824
070415, 070415
Yes
Jason Wendel, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Jason J. Wendel, M.D. Vanderbilt University
Vanderbilt University
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP