NCT03698968

Performance, Safety and Efficacy of PICO Device.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the purpose of continuing CE (Conformité Européene) Mark approval in accordance with MEDDEV 2.12-2

Detailed description

Although evidence exists which supports the positive effects of NPWT on take of skin grafts and flaps, there is limited evidence in relation to single-use systems such as PICO. Most previous studies have used traditional NPWT systems as part of their design. Though the technical applications of the traditional and newer single-use systems are comparable it is possible that some of the features of the latter may influence clinical outcomes. In addition to the limitations highlighted above, the cited studies have seldom assessed the ease of management and acceptability of NPWT systems. Although clinical outcomes may be considered paramount, these usability factors could also play a key role in ensuring compliance with negative pressure protocols. Although evidence exists which supports the positive effects of NPWT on take of skin grafts and flaps, there is limited evidence in relation to single-use systems such as PICO. Most previous studies have used traditional NPWT systems as part of their design. Though the technical applications of the traditional and newer single-use systems are comparable it is possible that some of the features of the latter may influence clinical outcomes. In addition to the limitations highlighted above, the cited studies have seldom assessed the ease of management and acceptability of NPWT systems. Although clinical outcomes may be considered paramount, these usability factors could also play a key role in ensuring compliance with negative pressure protocols. The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the purpose of continuing CE (Conformité Européene) Mark approval in accordance with MEDDEV 2.12-2. The PICO system has recently been updated with minor modifications that make the system silent during wear. S \& N also wish to collect PMCF data in the indications of knee and abdominal incisions in order to make retrospective comparisons with data previously collected for these indications. The aim of this study is therefore to assess whether the PICO 7 system is a safe and effective therapy for surgically closed incisions, skin grafts and flaps. Effectiveness will be defined by the ability of the system to deliver negative pressure and handle exudate and by percentage of successful skin graft or flap survival at Day 14. A summary of known and potential risks and benefits to humans of each test article can be found in the Instructions for Use of PICO 7.

Conditions

• Wound Heal

Interventions

Type	Name	Description
DEVICE	Negative Pressure Wound Therapy	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 1 week.

Timeline

• Start date: 2018-11-06
• Primary completion: 2019-06-18
• Completion: 2019-06-18
• First posted: 2018-10-09
• Last updated: 2019-09-18

Locations

11 sites across 2 countries: Switzerland, United Kingdom