Randomized Double-Blind Controlled Clinical Trial

Chronic Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04320628
• Other study ID #: ANTISEPTIC1
• Status: Completed
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: SerenaGroup, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Adult patients with acute or chronic wounds that have been present for a minimum of 4 weeks.

2. A signed and dated informed consent form.

3. Subject is willing and able to comply with instructions and scheduled visits.

Exclusion Criteria:

1. The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety.

2. The subject's wound has not been present for at least 4 weeks.

Related Conditions & MeSH terms

• Acute Wounds
• Chronic Wounds
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Serena Group Research Institute	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
SerenaGroup, Inc.	Anacapa Technologies Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in bacterial bioburden	The reduction in bacterial bioburden as determined by the MolecuLight Procedure (MiX) between normal saline (NSS) and sodium hypochlorite (NaOCl) wound washing.	4 weeks
Secondary	Healing rate	The effect on healing (surface area reduction) at a surrogate endpoint of 4 weeks between wounds washed with NaOCl vs wounds washed with NSS.	4 weeks
Secondary	Pain Score (PEG)	PEG Scale Assessing Pain Intensity and Interference (Pain, Enjoyment, General Activity) The difference in pain scores (PEG) between subjects treated with NaOCl vs, NSS.It consists of three 1-10 rating scales: numerical, enjoyment of life and general activity.; The subject indicates a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by word descriptors at each end, as "no pain" on the left side and "Pain as bad as you can imagine" on the right side of the number line. The number 0 represents "no pain", the number 5 represents "moderate pain" and the number 10 represents the "worst possible pain".	4 weeks
Secondary	Adverse Events	The difference in adverse events between subjects treated with NaOCl vs, NSS	4 weeks