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A Clinical Study to Assess the Safety and Clinical Performance of a New Dressing (PICO7Y) in Breast Surgery Patients

NCT03835845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-06-21

No results posted yet for this study

Summary

The purpose of the study is to assess the use of a wound dressing system called PICO7Y following a two-sided breast surgery. PICO7Y is a new dressing system made to treat two incisions/wounds at the same time, and the purpose of this study is to check how the dressing is working by looking at data on how well the dressing performs while you wear it and to check if doctors and patients are happy with it.

PICO7Y is based on another dressing called PICO.

Conditions

  • Oncoplastic Breast Surgery
  • Bilateral Surgery

Interventions

DEVICE

PICO7Y

The PICO 7Y pump maintains NPWT at -80 mmHg (nominal) to two wound surfaces simultaneously. Exudate is managed by the dressings through a combination of absorption and evaporation of moisture through the outer film. The PICO 7Y kit is intended to be used for up to 7 days on low exuding wounds. For moderately exuding wounds the system is intended to be used for up to 4 days without a dressing change. For 7 days use on moderately exuding wounds additional dressings will be supplied.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • John Murphy, MBChB · Oncoplastic Breast Surgeon

  • Brian Gilchrist, PhD · Smith & Nephew - Global Clinical Strategy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • Netherlands
  • United Kingdom

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 NCT03835845 on ClinicalTrials.gov