Patient Performed Tissue Expansion for Two-stage Alloplastic Breast Reconstruction

NCT04781907 | Withdrawn

• 5 other identifiers: 2020-1704A539730SMPH/SURGERY/DENTL-PLASTC SRGYUW20171Protocol Version 2/25/2021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (2)

• 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

• Incidence of Adverse Events

  Adverse events including - wound dehiscence, seroma, hematoma, extrusion, capsular contracture

  up to 6 months

Secondary Outcomes (2)

• Number of Right and Left breast tissue expanders successfully exchanged from expander to implant

  up to 6 months

• Incidence of Adverse Events in Left vs Right Breast Tissue Expansion

  up to 6 months

Other Outcomes (1)

• Participant Satisfaction Survey Score

  up to 6 months

Study Arms (2)

Home Expansion Group

EXPERIMENTAL

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.

Procedure: Tissue Expansion

Control Group

NO INTERVENTION

Standard of Care

Interventions

Tissue Expansion PROCEDURE

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

Home Expansion Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Tissue Expansion

Intervention Hierarchy (Ancestors)

Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Samuel Poore, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)