Breast Cancer Clinical Trial
Official title:
Tissue Expansion in Breast Reconstruction Without Drains: A Study Using a Tissue Expander That Collects Periprosthetic Fluid
The primary objective of this small feasibility pilot study is to demonstrate that implant-based breast reconstruction (after treatment for cancer) can successfully be performed without prolonged drain placement, using a tissue expander with a reservoir and in-office transcutaneous fluid aspiration. Secondly, the investigators aim to provide enough confidence in this technique that a larger study can be performed to demonstrate fewer complications (infection, drain-related pain and re-operation rates) when compared to the use of conventional tissue expanders and/or implants with prolonged drain placement.
Patients electing to have staged, implant-based, bilateral breast reconstruction at the time
of mastectomy (for either cancer or cancer prevention) will undergo a standardized
subpectoral tissue expander placement (using the Sientra AlloX2 dual-port device) on each
side of the chest with a single piece of acellular dermal matrix (ADM). A single drain in the
subcutaneous pocket of each breast will be used and removed on the first post-operative day.
Patients will be admitted for overnight observation in the hospital. Each post-operative day
fluid will be aspirated from each reservoir port using a standard sterile technique, and the
volume recorded. After discharge, patients will be seen in the office within one week of
discharge and fluid aspirated from each expander using the reservoir ports, and the volume
shall be recorded. The aspiration will be repeated weekly until expansion is completed and/or
the amount of fluid aspirated is less than 10 cc.
Patients will be asked to complete a 7 item multiple-choice questionnaire regarding their
attitudes about their breast reconstruction, first at completion of tissue expansion and
finally at their first follow-up visit following placement of permanent breast implants.
This study utilizes FDA 510k-classified devices that allow removal of fluid without drains,
in lieu of more conventional expanders, allowing for the avoidance of prolonged drain usage.
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