PICO14.WND.PRO.2019.03/PICO14 STUDY

  • Research type

    Research Study

  • Full title

    A prospective, study to evaluate the safety and performance of PICO 14 in the management of acute and chronic wounds

  • IRAS ID

    276466

  • Contact name

    Sudheer Karlakki

  • Contact email

    Sudheer.Karlakki@rjah.nhs.uk

  • Sponsor organisation

    Smith+Nephew

  • Clinicaltrials.gov Identifier

    NCT05234632

  • Clinicaltrials.gov Identifier

    NIHR CRN, application in process; Clinicaltrial.gov, application in process

  • Duration of Study in the UK

    1 years, 6 months, 2 days

  • Research summary

    PICO14 is a new dressing system made to treat surgical incisions or chronic wounds, and the purpose of this study is to check how the dressing is working and to check patient and clinician satisfaction.
    PICO14 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 PICO14 is PICO has provides treatment for up to 7 days whilst PICO14 can provide therapy for up to 14 days.

    Some evidence exists which supports the positive effects of NPWT in surgical closed incisions and chronic wounds.
    The aim of this study is therefore to assess the safety and clinical performance of the PICO 14 system in delivering NPWT. This study is designed to fulfil the requirements of a PICO14 Post Market Clinical Follow up.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    20/NW/0175

  • Date of REC Opinion

    15 May 2020

  • REC opinion

    Further Information Favourable Opinion