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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

Must not have

Residual gross tumor at intended expansion site

Current or prior infection at intended expansion site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am having a two-stage breast reconstruction with an expander.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I still have visible tumor where they plan to treat me.

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I have had an infection where my surgery is planned.

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I have or will receive radiation that causes significant scarring where my tissue expander is placed.

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I had issues with breast implant or tissue expansion in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events

Percent of Participants who had their breast tissue expanders successfully exchanged from expander to implant

Secondary study objectives

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 study objectives

Participant Satisfaction Survey Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met