Randomized Double-Blind Controlled Clinical Trial

Status Completed

Clinical Trial Summary

The study is a randomized double-blind controlled clinical trial designed to compare the ability of NaOCl to NSS in the reduction of bacterial burden in nonhealing acute and chronic wounds.

Clinical Trial Description

The study is a randomized double-blind controlled clinical trial designed to compare the ability of NaOCl to NSS in the reduction of bacterial burden in nonhealing acute and chronic wounds. Using the generally accepted surrogate endpoint of surface area reduction at 4 weeks, the study will also compare the healing of subjects utilizing NaOCl vs. NSS. After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MiX). The subject is then randomized to one of two arms: target ulcer cleansed with NaOCl or NSS. After cleansing the wound a second MiX is performed. The subject is given a four-week supply of either NaOCl or NSS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04320628
Study type	Interventional
Source	SerenaGroup, Inc.
Contact
Status	Completed
Phase	N/A
Start date	May 20, 2020
Completion date	March 1, 2022

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