Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center University of Michigan The University of North Carolina, Chapel Hill
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00639106

Purpose

Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest. Following your surgery, the tissue expander is gradually filled with salt water over a period of months. Once the expander is filled to the size of your new breast, a second operation is performed. At this time, the tissue expander is removed and a permanent breast implant is placed. This is a standard procedure. We are interested in learning about the use of AlloDerm in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in order to cover and protect a tissue expander. We want to know if the use of AlloDerm can decrease your pain or discomfort after surgery and after the filling of your tissue expander.

AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your body to reject it are removed. When it is placed in your chest, your own cells will then grow into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will either have reconstruction with AlloDerm or without AlloDerm.

Condition	Intervention	Phase
Breast Cancer	Procedure: Alloderm, Questionnaires Procedure: Without ALLODERM, Questionnaires	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Breast Reconstruction Cancer Mastectomy Surgery

Drug Information available for: BaseLine

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

whether using Alloderm to create the inferior-medial portion of the expander pocket will decrease patient-reported pain in both the immediate, post-operative period and during the expansion phase. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine if the use of Alloderm will decrease patient-reported sensory morbidity in both the immediate, post-operative period and during the expansion phase. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
To evaluate whether the use of Alloderm in tissue expander/implant reconstruction affects the rate of postoperative expansion and in-hospital narcotic use. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
To examine if the use of Alloderm will impact both chronic breast pain and sensory morbidity. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
To evaluate patient satisfaction following postmastectomy, tissue expander-implant reconstruction with and without the use of Alloderm. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
To examine the effect of Alloderm on the overall aesthetic outcome, including the formation of capsular contracture, following tissue expander/implant reconstruction. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	98
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Expander Placement WITH Alloderm	Procedure: Alloderm, Questionnaires All patients will undergo placement of a temporary tissue expander immediately following mastectomy.Patients will undergo the surgical creation of an expander pocket using implantable Alloderm.
B: Active Comparator Expander Placement WITHOUT Alloderm	Procedure: Without ALLODERM, Questionnaires A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who undergo immediate, postmastectomy, tissue expander/implant reconstruction
Patients ≥ 21 and ≤ 75 years of age

Exclusion Criteria:

Patient refusal
Patients who will undergo any of the following:
Single-stage implant reconstruction
Combined autogenous tissue expander/implant reconstruction
Patients with a history of prior irradiation
Patients with a history of prior surgery with breast implants
Patients with a history of prior axillary lymph node dissection
Patients who are pregnant

The following eligibility will be confirmed at the time of surgery.

Patients who are deemed intraoperatively by the attending surgeon to have significant mastectomy flap ischemia.
Patients who have an axillary lymph node dissection at the time of mastectomy (Patients undergoing sentinel lymph biopsy are eligible)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639106

Contacts

Contact: Joseph Disa, MD		disaj@mskcc.org
Contact: Colleen McCarthy, MD		mccarthc@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Joseph Disa, MD disaj@mskcc.org
Contact: Colleen McCarthy, MD mccarthc@mskcc.org
Principal Investigator: Joseph Disa, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

University of Michigan

The University of North Carolina, Chapel Hill

Investigators

Principal Investigator:

Joseph Disa, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Joseph Disa, MD )
Study ID Numbers:	08-024
Study First Received:	March 12, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00639106 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Breast expander
Breast reconstruction
implants

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009