Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments alloderm, questionnaires, without alloderm, questionnaires
Phase phase 3
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator University of Michigan
Start date March 2008
End date March 2016
Trial size 98 participants
Trial identifier NCT00639106, 08-024

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Expander Placement WITH Alloderm
alloderm, questionnaires Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second
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.
(Active Comparator)
Expander Placement WITHOUT Alloderm
without alloderm, questionnaires Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second
A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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
To examine if the use of Alloderm will impact both chronic breast pain and sensory morbidity.
time frame: 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
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

Eligibility Criteria

Female participants from 21 years up to 75 years old.

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)

Additional Information

Official title The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
Principal investigator Joseph Disa, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.