NCT05234632

Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds

A Prospective Study to Evaluate the Safety and Performance of PICO 14 in the Management of Acute and Chronic Wounds

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot ulcers), dehisced surgical wounds and closed surgical incisions. The study comprises the Post Market Clinical Follow-up (PMCF) for a new variant of an established product. PICO 14 is based on another dressing called PICO. The primary objective is to evaluate functional performance of PICO 14 through verification of delivery of negative pressure and wound exudate management.

Conditions

• Surgical Incision
• Ulcer Foot
• Ulcer Venous
• Ulcer, Leg
• Pressure Ulcer
• Wound Dehiscence

Interventions

Type	Name	Description
DEVICE	PICO 14 single-use Negative Pressure Wound Therapy System	The PICO14 device delivers negative pressure across the wound bed or closed incision and surrounding area, and exudate is managed by the dressing through a combination of absorption and evaporation of moisture through the outer film.

Timeline

• Start date: 2020-09-22
• Primary completion: 2022-09-23
• Completion: 2022-09-23
• First posted: 2022-02-10
• Last updated: 2025-06-06
• Results posted: 2025-01-28

Locations

6 sites across 2 countries: Germany, United Kingdom