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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Michigan
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00639106
First received: March 12, 2008
Last updated: August 22, 2012
Last verified: August 2012
History of Changes
  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 3

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

Resource links provided by NLM:

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 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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.
Other Names:
  • Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second
  • and third injection and following completion of expansion will take approximately 20 minutes
  • to complete.
  • It is expected that the panel of questionnaires administered at baseline (prior to mastectomy)
  • and at 6 and 12 months following the exchange procedure will take approximately 45 minutes
Active Comparator: B
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.
Other Names:
  • Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second
  • and third injection and following completion of expansion will take approximately 20 minutes
  • to complete.
  • It is expected that the panel of questionnaires administered at baseline (prior to mastectomy)
  • and at 6 and 12 months following the exchange procedure will take approximately 45 minutes

  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

Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
University of Michigan
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 by Memorial Sloan-Kettering Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00639106     History of Changes
Other Study ID Numbers: 08-024
Study First Received: March 12, 2008
Last Updated: August 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast expander
Breast reconstruction
implants
08-024

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013