Single Use PICO NPWT Post-Market Safety and Efficacy Study
Research type
Research Study
Full title
A prospective follow up study to assess performance, safety and efficacy of the PICO 7 NPWT system for surgically closed incision sites and skin grafts
IRAS ID
248769
Contact name
Sudheer Karlakki
Contact email
Sponsor organisation
Smith & Nephew
Clinicaltrials.gov Identifier
Application being processed, NIHR CRN; Application being processed, Clintrials.gov
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
There is a significant amount of clinical evidence to show that NPWT may reduce oedema, increase healing and reduce chance of infection, through maintenance of pressure therapy, in closed incisions, but limited clinical evidence on skin grafts and flaps. In order to meet MDR regulation this study is being complete to assess performance efficacy and safety in skin grafts. In addition a minor modification has been made to the pump to reduce noise level. Evidence on a small number of abdominal and knee incisions are also being collected to assess that the pump works in the same way as previously on these indications.\nSubjects with abdominal incisions, skin grafts and knee incisions following knee surgery will be recruited to the study and receive NPWT for 7 days. Functional performance of the system will be assessed through the use of pressure data loggers and acceptability of the device as assessed by patient and clinician. Safety will be assessed with a 30 day follow up to assess complications and device related events.\n
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0162
Date of REC Opinion
31 Jul 2018
REC opinion
Further Information Favourable Opinion