Breast Reconstruction Clinical Trial
Official title:
Patient Performed Tissue Expansion for Two-stage Alloplastic Breast Reconstruction
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 that a motivated patient who learns and demonstrates proper technique can safely perform tissue expansions at home, with no increase in complications or problems with reconstruction. 30 participants will be recruited for this study, 10 into a Home Expansion Group, and 20 into a Control Group.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Participant Satisfaction Survey Score | Exit survey with 5-point Likert scale ratings on patient's experiences regarding tissue expansion process, where higher scores indicate increased satisfaction. | up to 6 months | |
Primary | Percent of Participants who had their breast tissue expanders successfully exchanged from expander to implant | Clinically, the tissue expander is only temporary and the main goal is to get patient to their permanent breast implant | up to 6 months | |
Primary | Incidence of Adverse Events | Adverse events including - wound dehiscence, seroma, hematoma, extrusion, capsular contracture | up to 6 months | |
Secondary | Number of Right and Left breast tissue expanders successfully exchanged from expander to implant | Participants serve as internal control, with the right breast being expanded by self and left breast being expanded by clinical staff per usual protocol. | up to 6 months | |
Secondary | Incidence of Adverse Events in Left vs Right Breast Tissue Expansion | Participants serve as internal control, with the right breast being expanded by self and left breast being expanded by clinical staff per usual protocol. | up to 6 months |
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