Pilot study designed to assess functionality of a low-cost negative pressure wound therapy system in patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps, grafts and surgical incisions

Healyx Labs0 sites15 target enrollmentMay 30, 2018

Overview

No summary available.

Registry

who.int

Start Date

May 30, 2018

End Date

May 26, 2018

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Healyx Labs

•1\. Patient is 18 years of age or older
•2\. Patient presents with an open wound
•3\. Patient is able to understand study requirements, is willing to undergo subject procedures, provide any required subject feedback, and provide informed consent to participate in the study

•1\. Patient who is pregnant or nursing
•2\. Patient with a non\-survivable wound, life expectancy of 7 days or less
•3\. Patient’s wound is of malignant or vasculitis origin, or shows presence of necrotic tissue
•4\. Patient’s wound has active bleeding, exposed blood vessels or organs
•5\. Patient with wound\-related comorbidities, including diabetic ketoacidosis, Hyperglycaemic Hyperosmolar Nonketotic Coma, vascular disease, or arthritis
•6\. Patient currently using medications that cause immune suppression
•7\. Patient with wound considered too difficult to seal based on location
•8\. Patient unable to understand study or provide informed consent to participate in the study