Clinical Evaluation of a Novel Incisional NPWT System

Status Active, not recruiting

Clinical Trial Summary

A study of the first clinical use in humans of a novel NPWT system (npSIMS) to assess the suitability, safety and efficacy of the system for the management of closed surgical wounds

Clinical Trial Description

The purpose of this investigation is to test the functionality of a novel, non-electric NPWT device: npSIMS (negative pressure Surgical Incision Management System) from Aatru Medical LLC (Ohio, USA) which uses an exothermic chemical process to extract the oxygen from the air contained within the dressing (air contains 21% O2) and hence bring and maintain the system to between -160 and -80 mmHg below atmospheric pressure (760 mmHg). The dressing and the chemical reaction pump module can be manufactured for significantly less than the cost of electromechanical NPWT systems and can be profitably marketed at a discount to the cost of existing commercial devices. The Aatru Medical NPWT system could transform the economics and increase the availability of this therapy across the world. ;

Study Design

Related Conditions & MeSH terms

Surgical Wound

Clinical Trial Details

NCT number	NCT04488666
Study type	Interventional
Source	Aatru Medical LLC
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 26, 2021
Completion date	February 2024

View Details

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