MedTrace Logo

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

NCT05234632 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2025-06-06

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Rachel Jahnke · Smith & Nephew, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-22
Primary Completion
2022-09-23
Completion
2022-09-23

Countries

  • Germany
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05234632 on ClinicalTrials.gov