NCT04102865

Performance, Safety and Efficacy of NPWT Device

NPWT Pre-registration Study: A Prospective, Multicentre Trial to Assess Performance, Safety and Efficacy of a Single-use NPWT Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Smith \& Nephew are assessing a new investigational single use NPWT system.

Detailed description

Smith \& Nephew are assessing a new investigational 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. Subjects with abdominal incisions 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.

Conditions

• Wound Healing and Prevention

Interventions

Type	Name	Description
DEVICE	Negative-Pressure Wound Therapy (NPWT)	Investigational single use disposable negative pressure system. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 7 days.

Timeline

• Start date: 2019-07-12
• Primary completion: 2022-07-06
• Completion: 2022-07-27
• First posted: 2019-09-25
• Last updated: 2024-12-11
• Results posted: 2024-11-21

Locations

8 sites across 1 country: United Kingdom