Clinical trial NCT03784859: Tissue Expansion in Breast Reconstruction Without Drains
Official title: Tissue Expansion in Breast Reconstruction Without Drains: A Study Using a Tissue Expander That Collects Periprosthetic Fluid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Hereditary Breast and Ovarian Cancer Syndrome
Breast Implant; Complications
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Tiger Biosciences, LLC.
First posted: 2018-12-24
Enrollment: 5
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women over the age of 21 with breast cancer or a gene that increases the risk of breast cancer who elect to undergo bilateral mastectomies and two-stage implant-based reconstruction using tissue expanders and permanent implants.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing bilateral breast reconstruction following mastectomy (performed to treat stage I-III breast cancer or for prevention of breast cancer).
* Non-smokers
* BMI less than 31
* No other significant surgical risk factors that make elective use of implants dangerous (e.g., presence of a pacemaker, frail health, dependence on blood thinners, uncontrolled diabetes, bleeding tendencies, autoimmune disorders, immune compromise)

Exclusion Criteria:

* Unilateral mastectomy patients
* Current smokers
* Those with bleeding dyscrasias or clotting disorders
* Those who have had or will have a full axillary lymph node dissection
* Cases where there is an unusually high degree of bleeding intra-operatively (more than 150 cc)
* Those with a BMI greater than 30
* Those with history of prior breast surgery (aside from lumpectomy or needle biopsy)
* Those with a history of prior breast radiation
* Those with stage IV or unresectable breast cancer
* Significant surgical risk factors that make elective use of implants dangerous (e.g., presence of a pacemaker, frail health, dependence on blood thinners, uncontrolled diabetes, bleeding tendencies, autoimmune disorders, immune compromise)

Primary outcomes:
measure: Number of patients with successful breast reconstruction using reservoir-expanders
timeFrame: 4-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Edward C Ray, MD
role: PRINCIPAL_INVESTIGATOR
References:
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