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PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

NCT01640366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-02-28

Study results available
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Summary

The purpose of this study is to see if the use of a single-use negative pressure wound therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing complications following breast reduction surgery and to assess the medium-term aesthetic appearance and quality of the resultant scar, compared with standard of care dressings.

Conditions

  • Delayed Healing

Interventions

DEVICE

PICO

Single-use Negative Pressure Wound Therapy System

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert D Galiano, MD · Northwestern University Feinberg School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-04-30
Completion
2014-07-31
FDA Device
Yes

Countries

  • United States
  • France
  • Netherlands
  • South Africa

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 NCT01640366 on ClinicalTrials.gov