There is a significant amount of clinical evidence to show that NPWT may reduce oedema, increase healing and reduce infection rates through the maintenance of pressure therapy in closed incisions. However, there is currently only limited clinical evidence on skin grafts and flaps. In order to meet MDR regulations, this study is being carried out to assess the performance, efficacy and safety of NPWT in skin grafts. Additionally, a minor modification has been made to the pump to reduce its noise levels. Evidence from a small number of abdominal and knee incisions are also being collected as control data to assess that the pump works in the same way as previously indicated on these sites. Subjects with abdominal incisions, skin grafts and knee incisions following surgery will be recruited in to the study and receive NPWT for 7 days. Functional performance of the system will be assessed through the use of pressure data loggers by patient and clinician. Safety will be assessed with a 30 day follow up to assess complications and device related events.
A follow up study to assess performance, safety and efficacy of the PICO 7 NPWT system for surgically closed incision sites and skin grafts
This trial aims to assess the functional clinical performance of PICO 7 (negative pressure wound therapy)NPWT system over 7 days therapy through verification of delivery of negative pressure and wound exudate management.
Prof Steve Jeffery
Mr Sudheer Karlakki