Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction

NCT02725801 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-09-04

Study results available
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Summary

Appropriate patients undergoing going immediate breast reconstruction with tissue expanders following mastectomy will be randomized to receive one-port or two-ports tissue expanders. Their clinical course, complications, and outcome will be analyzed.

Conditions

Interventions

DEVICE

Allergen one-port tissue expander placement

patients will be randomized to receive a one port or two port tissue expander for breast reconstruction

DEVICE

AlloX2 two-port tissue expander placement

patients will be randomized to receive a one port or two port tissue expander for breast reconstruction

Sponsors & Collaborators

  • Lesley Wong

    lead OTHER

Principal Investigators

  • Lesley Wong, MD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-07-19
Completion
2020-04-01

Countries

  • United States

Study Locations

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Entities

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 NCT02725801 on ClinicalTrials.gov