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Randomized Double-Blind Controlled Clinical Trial

NCT04320628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-03-14

No results posted yet for this study

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.

Conditions

  • Chronic Wounds
  • Acute Wounds

Interventions

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

Sponsors & Collaborators

  • Anacapa Technologies Inc

    collaborator UNKNOWN

  • SerenaGroup, Inc.

    lead NETWORK

Principal Investigators

  • Thomas E Serena, MD,FACS · Serena Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-20
Primary Completion
2022-02-01
Completion
2022-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04320628 on ClinicalTrials.gov