Status:
WITHDRAWN
Prepectoral vs Partial Subpectoral Two-Stage Implant-Based Breast Reconstruction
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Breast Reconstruction Following Mastectomy
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the to analyze the patient satisfaction and complication rates under controlled conditions of the increasingly popular prepectoral technique for implant-bas...
Detailed Description
This is a single center, single-blinded, randomized clinical trial involving adult women undergoing two-stage implant-based breast reconstruction for either breast cancer or breast cancer risk reducti...
Eligibility Criteria
Inclusion
- \- Undergoing two-stage implant-based breast reconstruction for either breast cancer or breast cancer risk reduction
Exclusion
- Active use of any tobacco products
- Uncontrolled diabetes defined by HbA1c greater than 7.5%
- Class II obesity or higher defined by a body mass index equal or greater than 35 kg/m2
- History of radiation to the affect breast or chest
- Immunocompromised patients
- Clinical evidence of significant mastectomy flap ischemia prior to the initiation of the reconstructive procedure
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04874402
Start Date
October 1 2023
End Date
June 30 2025
Last Update
June 18 2023
Active Locations (1)
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1
Cleveland Clinic Florida, Case Comprehensive Cancer Center
Weston, Florida, United States, 33331