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

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: Breast Cancer
• Intervention / Treatment: Procedure: Alloderm, Questionnaires; Procedure: Without ALLODERM, Questionnaires

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• 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

General Publications

• McCarthy CM, Lee CN, Halvorson EG, Riedel E, Pusic AL, Mehrara BJ, Disa JJ. The use of acellular dermal matrices in two-stage expander/implant reconstruction: a multicenter, blinded, randomized controlled trial. Plast Reconstr Surg. 2012 Nov;130(5 Suppl 2):57S-66S. doi: 10.1097/PRS.0b013e31825f05b4.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

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: Breast reconstruction; implants; Breast expander; 08-024
• Other Study ID Numbers: 08-024