Your session is about to expire
← Back to Search
Other
Self-Administered Tissue Expansion for Breast Reconstruction
N/A
Waitlist Available
Led By Samuel Poore, MD, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing two stage bilateral alloplastic breast reconstruction with tissue expander (either immediate or delayed)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial will study whether patients can safely learn to do their own tissue expansions at home, with no increase in complications or problems with reconstruction.
Who is the study for?
This trial is for individuals undergoing two-stage alloplastic breast reconstruction who can attend clinic visits every 1-2 weeks. They must be able to learn and perform tissue expansions at home, have signed consent, and not have a history of certain conditions like psychological disorders, substance misuse, or complications that could affect the expansion process.Check my eligibility
What is being tested?
The study tests if patients can safely do their own tissue expansions at home as part of breast reconstruction. It involves 30 participants: 10 will expand their own tissues at home while the other 20 will serve as a control group following standard procedures.See study design
What are the potential side effects?
While specific side effects are not listed in this summary, potential risks may include infection, improper expansion technique leading to complications with reconstruction, or issues related to individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a two-stage breast reconstruction with an expander.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events
Percent of Participants who had their breast tissue expanders successfully exchanged from expander to implant
Secondary outcome measures
Incidence of Adverse Events in Left vs Right Breast Tissue Expansion
Number of Right and Left breast tissue expanders successfully exchanged from expander to implant
Other outcome measures
Participant Satisfaction Survey Score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home Expansion GroupExperimental Treatment1 Intervention
Participants in home expansion group will perform the saline injection for their right tissue expander under clinic staff supervision on their 2nd and 3rd expansion. Beginning their 4th expansion, participants will perform saline injection at home prior to their regularly scheduled clinic visit.
Group II: Control GroupActive Control1 Intervention
Standard of Care
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,357 Total Patients Enrolled
Samuel Poore, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or will receive radiation that causes significant scarring where my tissue expander is placed.I am not on medications that increase my risk of complications.I have a health condition like severe autoimmune disease, uncontrolled diabetes, or a BMI over 35.You have a history of mental health issues or problems with drugs or alcohol that may make it unsafe for you to participate in home expansions.I still have visible tumor where they plan to treat me.I have had an infection where my surgery is planned.I had issues with breast implant or tissue expansion in the past.I can attend clinic visits every 1-2 weeks for treatment.I can understand, learn, and manage treatments at home.You are currently smoking tobacco.My skin or tissue is not healthy enough for expansion due to poor blood flow or healing issues.I am having a two-stage breast reconstruction with an expander.
Research Study Groups:
This trial has the following groups:- Group 1: Home Expansion Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for volunteers to join this clinical experiment?
"According to clinicaltrials.gov, this trial is not currently enrolling patients; it was initially posted on December 1st 2022 and last edited on June 27th 2022. However, 23 other medical studies are actively recruiting participants at the moment."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger