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Randomized Double-Blind Controlled Clinical Trial

2020-03-28 03:55:36 | BioPortfolio

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.

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

Conditions

Chronic Wounds

Intervention

AnaSept®, NSS

Status

Not yet recruiting

Source

SerenaGroup, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-03-28T03:55:36-0400

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Medical and Biotech [MESH] Definitions

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