Tissue Expansion in Breast Reconstruction Without Drains
Completed
Conditions studied: Breast Cancer, Hereditary Breast and Ovarian Cancer Syndrome, Breast Implant; Complications
In brief
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.
Key facts
- Study ID
- NCT03784859
- Run by
- Cedars-Sinai Medical Center
- People needed
- 5
- Starts
- 2019-02-25
- Expected to finish
- 2020-10-02
- Last updated by the study team
- 2020-10-06
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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