Single Use NPWT Pre-Registration Study
Research type
Research Study
Full title
NPWT Pre-Registration Study: A Prospective, Multicentre Trial to assess performance, and safety of a single-use negative pressure system.
IRAS ID
236897
Contact name
Steven Jeffery
Contact email
Sponsor organisation
Smith & Nephew
Clinicaltrials.gov Identifier
SURG 37295, NIHR CRN; Application being processed, Clintrials.gov
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
Smith & Nephew are assessing a new single use NPWT system.
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, and some limited clinical evidence on skin grafts. The proposed clinical strategy is to conduct a study assessing performance, and safety of the new single use NPWT system in order to assess whether the same benefits of other NPWT systems on the market can be applied to therapy provided with the new system. Subjects with abdominal incisions, skin grafts and knee incisions following knee surgery will be recruited to the study and receive NPWT for 7 days. The performance of the system will be logged by the device and acceptability of the device will be assessed by patient and clinician. Safety will be assessed with a 30 day follow up to assess complications and device related events.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
18/NW/0359
Date of REC Opinion
20 Nov 2018
REC opinion
Further Information Favourable Opinion