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

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00616824

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Breast Reconstruction Mastectomy

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
Traditional Method: Active Comparator 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
Dermamatrix Arm: Experimental 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

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:	Vanderbilt University Department of Plastic Surgery ( J. Jason Wendel, M.D. )
Study ID Numbers:	070415, 070415
Study First Received:	February 5, 2008
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00616824 History of Changes
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

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Postoperative Complications
Pain
Pain, Postoperative

ClinicalTrials.gov processed this record on September 10, 2009