Clinical trial NCT00639106: Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
Official title: The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast expander
Breast reconstruction
implants
08-024
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: University of North Carolina, Chapel Hill
First posted: 2008-03-19
Enrollment: 70
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

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.
timeFrame: 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.
timeFrame: conclusion of the study
measure: To evaluate whether the use of Alloderm in tissue expander/implant reconstruction affects the rate of postoperative expansion and in-hospital narcotic use.
timeFrame: conclusion of the study
measure: To examine if the use of Alloderm will impact both chronic breast pain and sensory morbidity.
timeFrame: conclusion of the study
measure: To evaluate patient satisfaction following postmastectomy, tissue expander-implant reconstruction with and without the use of Alloderm.
timeFrame: conclusion of the study
measure: To examine the effect of Alloderm on the overall aesthetic outcome, including the formation of capsular contracture, following tissue expander/implant reconstruction.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Joseph Disa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.