NCT04320628

Randomized Double-Blind Controlled Clinical Trial

Randomized Double-Blind Controlled Clinical Trial Comparing Sodium Hypochlorite Antiseptic to Normal Saline in Reducing Bioburden in Wounds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: SerenaGroup, Inc. · Network
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Wounds
• Acute Wounds

Interventions

Type	Name	Description
DEVICE	AnaSept®	AnaSept® AnaSept® Antimicrobial Skin and Wound Cleanser is a clear liquid consisting of 0.057% sodium hypochlorite (NaOCl) in an isotonic saline. It has a broad-spectrum of antimicrobial action inhibiting the growth of Staphlyococcus aureus, Psuedomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, Clostridium difficile, including antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), Vancomycin Resistant Enterococcus faecalis (VRE), Carbapenem Resistant E.coli (CRE) and Acinetobacter baumannii, that are commonly found in wound bed as well as fungi such as Candida albicans and Aspergillus niger. However, NaOCL is non-toxic to mammalian cells.
OTHER	NSS	NSS

Timeline

• Start date: 2020-05-20
• Primary completion: 2022-02-01
• Completion: 2022-03-01
• First posted: 2020-03-25
• Last updated: 2022-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study