Status:
WITHDRAWN
Patient Performed Tissue Expansion for Two-stage Alloplastic Breast Reconstruction
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Tissue Expansion
Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is designed to evaluate the feasibility and safety of patient performed tissue expansions in two-stage alloplastic breast reconstruction with tissue expanders. The investigators hypothesize...
Detailed Description
Two-stage tissue expander-to-implant reconstruction is the most common technique for breast reconstruction in the United States. Tissue expanders are used to increase the soft tissue envelope after ma...
Eligibility Criteria
Inclusion
- Undergoing two stage bilateral alloplastic breast reconstruction with tissue expander (either immediate or delayed)
- Able and willing to present for clinic visits every 1-2 weeks per tissue expansion protocol
- Physical, perceptual and cognitive capacity to understand, learn, perform and manage at-home expansions
- Provision of signed and dated informed consent form
Exclusion
- Failure to demonstrate proper tissue expander saline infiltration technique after two teachings and observations by clinic staff
- Tissue integrity unsuitable for tissue expansion (compromised vascularity, history of compromised wound healing, mastectomy skin flaps of questionable viability, excessively tight skin envelope)
- Residual gross tumor at intended expansion site
- Current or prior infection at intended expansion site
- Clinically significant fibrosis caused by previous irradiation or planned radiation therapy at intended expansion site during time expander is implanted
- History of failed tissue expansion/breast implant reconstruction
- Concomitant medications that may place subject at increased risk of complications (adjuvant chemotherapy, therapeutic anticoagulation, steroids, immunosuppressants)
- Current tobacco smoker
- Comorbid condition that may place subject at increased risk of complications (severe collagen vascular disease, poorly managed diabetes, BMI \> 35
- History of psychological condition, drug or alcohol misuse that may interfere with their ability to perform home expansions safely
- Participating in concurrent investigational drug or device study
- Pregnant women
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04781907
Start Date
June 1 2024
End Date
June 1 2025
Last Update
May 28 2024
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53792