NCT02458859

Trial of PICO Versus Standard Care in Chronic and Sub-acute Wounds

A 100 Patient, Prospective, Randomised, Clinical Evaluation Comparing Clinical and Health Economic Outcomes Between Patients With Chronic or Sub-acute Wounds Treated With Either PICO or Standard Care Dressings and a Qualitative Study to Explore the Experiences of Patients Receiving PICO With Particular Emphasis on Concordance

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomised Controlled Trial of PICO (a portable Negative Pressure Wound Therapy) versus standard care in patients with chronic and sub-acute wounds. Sample size 100 patients to investigate Time to healing, health economic and patient reported outcomes.

Detailed description

The current study is being conducted to assess the clinical and cost effectiveness of managing patients with a chronic or sub-acute wound in a community setting with PICO and to explore the patient experience and issues of concordance that affect patients treated with PICO. The study will provide information on the level of clinical benefit that PICO can deliver in the population studied in order to justify a sample size for a definitive evaluation of PICO and the study will further assess wound types that may benefit from treatment with PICO.

Conditions

• Wounds

Interventions

Type	Name	Description
DEVICE	PICO (single use portable negative pressure wound therapy)	Single use portable negative pressure wound therapy

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-06-01
• Last updated: 2018-02-13

Locations

20 sites across 2 countries: Canada, United Kingdom