PICO7Y Negative Pressure Wound Therapy system- CT1704P7Y
Research type
Research Study
Full title
An Observational, Prospective Multicentre Clinical Study to assess the safety and clinical performance of a New Single-use Negative Pressure Wound Therapy System (PICO 7Y) for the Simultaneous Management of Bilateral Closed Incisions in Oncoplastic Breast Surgery Patients
IRAS ID
258468
Contact name
John Murphy
Contact email
Sponsor organisation
Smith and Nephew
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Application being processed, Clinicaltrial.gov; Application being processed , NIHR CRN
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
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 and to check patient and clinician satisfaction.
PICO7Y is based on an existing dressing called PICO. PICO is a negative pressure dressing which manages wounds and surgical incisions, it is known as a Negative Pressure Wound Therapy (NPWT) system. The main difference between PICO and PICO7Y, is that PICO has one pump with tubing to one dressing and PICO7Y is a new dressing system that has recently been approved especially for when two incisions/wounds need to be treated at the same time. It has one pump and a special Y connector that allows the attachment of two tubes to two dressings at the same time.
Some evidence exists which supports the positive effects of NPWT in oncoplastic breast surgery closed incision wounds, there is no evidence in relation to single-use systems treating both wounds simultaneously like PICO7Y does.
The aim of this study is therefore to assess the safety and clinical performance of the PICO 7Y system in delivering NPWT simultaneously to two closed incisions following bilateral oncoplastic breast surgery. This study is designed to fulfil the requirements of a PICO 7Y Post Market Clinical Follow up.REC name
HSC REC A
REC reference
18/NI/0240
Date of REC Opinion
21 Jan 2019
REC opinion
Further Information Favourable Opinion