Status:
COMPLETED
Tissue Expansion in Breast Reconstruction Without Drains
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborating Sponsors:
Tiger Biosciences, LLC.
Conditions:
Breast Cancer
Hereditary Breast and Ovarian Cancer Syndrome
Eligibility:
FEMALE
21+ years
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 drai...
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 expan...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 2 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03784859
Start Date
February 25 2019
End Date
October 2 2020
Last Update
October 6 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048