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Clinical Trial Summary

Irrisept™ irrigation containing Chlorhexidine Gluconate (CHG) 0.05% in sterile water, is an irrigation method that may help reduce bacterial load considerably more than traditional saline irrigation.


Clinical Trial Description

The purpose of this clinical evaluation is to collect patient outcome data on Irrisept™ irrigation. This is a jet irrigation of 0.05% Chlorhexidine Gluconate (CHG) in sterile water delivered under pressure by manual compression of the bottle by the user. This treatment allows for management of bioburden in a wound through broad spectrum antimicrobial activity by the CHG as well as removal of debris from the wound bed. In this trial, participants with partial and full thickness diabetic foot ulcers (DFUs) - 'full skin thickness and extending through the subcutaneous or fat layers or to deeper structures such as tendon and fascia will receive standard of care treatment with indicated off-loading device (SOC) for their condition in addition to wound bed irrigation with Irrisept™ or saline Irrigation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06024590
Study type Interventional
Source Northern Illinois Foot and Ankle Specialists
Contact Lori Rotolo, BS
Phone 2168493574
Email lorirotolo@illinoisfoot.com
Status Recruiting
Phase Phase 4
Start date October 3, 2023
Completion date September 25, 2024

See also
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