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Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery

NCT02372305 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-07-18

No results posted yet for this study

Summary

FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction.

Conditions

  • Breast Neoplasm

Interventions

BIOLOGICAL

FlexHD

Patients will be randomized to receive FlexHD.

BIOLOGICAL

Alloderm

Patient will be randomized to receive Alloderm.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Pallavi A Kumbla, MD · UAMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-12-21
Completion
2017-12-21

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 NCT02372305 on ClinicalTrials.gov