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
255026
Contact name
John Murphy
Contact email
Sponsor organisation
Smith and Nephew
Clinicaltrials.gov Identifier
Application being processed, Clinicaltrial.gov; Application being processed , NIHR CRN
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Although 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. Previous studies have focused on NPWT systems with the ability to only supply negative pressure to a single wound and although the technical applications of the systems are comparable, application of the Y connection may represent a cost saving to the healthcare system. Furthermore use of a one NPWT device is likely to affect both patients and healthcare practitioners’ experiences. Existing studies have seldom assessed the ease of management and acceptability of NPWT systems. Although clinical outcomes are considered as the principal goal, these usability factors could also play a key role in ensuring compliance with negative pressure protocols.
A prospective, open-labelled, multicentre study to evaluate the clinical performance through the capacity of the system to provide uninterrupted negative pressure therapy and the lowest possible incidence (closer to zero) of system failure (leakage) in bilateral oncoplastic breast surgery wounds treated with the PICO 7Y system would fulfil this short fall in knowledge.
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 (PMCF) plan as detailed in the PICO Clinical Evaluation Report (CER). Oncoplastic breast surgery represents a key field of use for PICO 7Y, and it is expected to meet specific customer needs.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0361
Date of REC Opinion
27 Nov 2018
REC opinion
Unfavourable Opinion