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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Without ALLODERM, Questionnaires; Procedure: Alloderm, Questionnaires

• Registration Number: NCT00639106
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-19
• Status Verified: 2018-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-02
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Without ALLODERM, Questionnaires	Expander Placement WITHOUT Alloderm
A	Alloderm, Questionnaires	Expander Placement WITH Alloderm

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
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 patient satisfaction following postmastectomy, tissue expander-implant reconstruction with and without the use of Alloderm.	conclusion of the study

Trial Locations

Locations (3)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of North Carolina School of Medicine; 🇺🇸 Chapel Hill, North Carolina, United States