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

October 2, 2018 updated by: Memorial Sloan Kettering Cancer Center

The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
conclusion of the study
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
conclusion of the study
To examine if the use of Alloderm will impact both chronic breast pain and sensory morbidity.
Time Frame: conclusion of the study
conclusion of the study
To evaluate patient satisfaction following postmastectomy, tissue expander-implant reconstruction with and without the use of Alloderm.
Time Frame: conclusion of the study
conclusion of the study
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
conclusion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

University of Michigan
University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Joseph Disa, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2008

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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