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Patient Performed Tissue Expansion for Two-stage Alloplastic Breast Reconstruction

NCT04781907 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-05-28

No results posted yet for this study

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 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.

Conditions

  • Tissue Expansion
  • Breast Reconstruction

Interventions

PROCEDURE

Tissue Expansion

Tissue expanders are used to increase the soft tissue envelope after mastectomy to provide adequate and healthy coverage of prosthetic breast implants.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Samuel Poore, MD, PhD · University of Wisconsin, Madison

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04781907 on ClinicalTrials.gov