Randomized Double-Blind Controlled Clinical Trial

NCT04320628 | Completed FDA Device

• 1 other identifier: ANTISEPTIC1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Healing rate

  4 weeks

• Pain Score (PEG)

  4 weeks

• Adverse Events

  4 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Target ulcer cleansed with NaOCl. After cleansing the wound a second MiX is performed. The subject is given a four-week supply of NaOCl.

Device: AnaSept®

Control

PLACEBO COMPARATOR

Target ulcer cleansed with NSS. After cleansing the wound a second MiX is performed. The subject is given a four-week supply of NSS.

Other: NSS

Interventions

AnaSept® DEVICE

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.

Also known as: ANTISEPTIC

Experimental

NSS OTHER

NSS

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with acute or chronic wounds that have been present for a minimum of 4 weeks.
• A signed and dated informed consent form.
• Subject is willing and able to comply with instructions and scheduled visits.

You may not qualify if:

• The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety.
• The subject's wound has not been present for at least 4 weeks.

Sponsors & Collaborators

• SerenaGroup, Inc.: lead
• Anacapa Technologies Inc: collaborator

Study Sites (1)

Serena Group Research Institute

Pittsburgh, Pennsylvania, 15222, United States

Location

Study Officials

• Thomas E Serena, MD,FACS

  Serena Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This protocol is double-blinded. Subjects will be randomized 1:1 to have their wound cleansed with either NSS or NaOCl. Unblinded staff will prepare the solutions for the two arms the morning of the day of enrollment. NSS and NaOCl will be placed in labeled containers consistent with the randomization scheme. NaOCl has a faint odor of chlorine. In order to maintain the blind the containers will have chlorine placed on the outside of bottom of the container and in the treatment room an open container of chlorine bleach will be safely positioned as to avoid injury to subjects and research personnel, but close enough to provide a mild chlorine smell in the room. Finally, the unblinded research staff will provide the subject with their 4-week supply of NSS or NaOCl to take home.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: AnaSept® AnaSept® Antimicrobial Skin and Wound Cleanser is a clear liquid consisting of 0.057% sodium hypochlorite (NaOCl) in an isotonic saline.

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: May 20, 2020
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)