Randomized Double-Blind Controlled Clinical Trial

• Sponsor: SerenaGroup, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT04320628
• Collaborator: Anacapa Technologies Inc (Other)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.4
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Wounds; Acute Wounds	Device: AnaSept®; Other: NSS	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: AnaSept® AnaSept® Antimicrobial Skin and Wound Cleanser is a clear liquid consisting of 0.057% sodium hypochlorite (NaOCl) in an isotonic saline.AnaSept® AnaSept® Antimicrobial Skin and Wound Cleanser is a clear liquid consisting of 0.057% sodium hypochlorite (NaOCl) in an isotonic saline.
• Masking: Double (Participant, Investigator)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Randomized Double-Blind Controlled Clinical Trial Comparing Sodium Hypochlorite Antiseptic to Normal Saline in Reducing Bioburden in Wounds
• Actual Study Start Date: May 20, 2020
• Actual Primary Completion Date: Feb 1, 2022
• Actual Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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®; 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 Names: ANTISEPTIC
Placebo Comparator: Control 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; NSS

Outcome Measures

Primary Outcome Measures

1. Reduction in bacterial bioburden [4 weeks]

   The reduction in bacterial bioburden as determined by the MolecuLight Procedure (MiX) between normal saline (NSS) and sodium hypochlorite (NaOCl) wound washing.

Secondary Outcome Measures

1. Healing rate [4 weeks]

   The effect on healing (surface area reduction) at a surrogate endpoint of 4 weeks between wounds washed with NaOCl vs wounds washed with NSS.

2. Pain Score (PEG) [4 weeks]

   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".

3. Adverse Events [4 weeks]

   The difference in adverse events between subjects treated with NaOCl vs, NSS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Serena Group Research Institute	Pittsburgh	Pennsylvania	United States	15222

Sponsors and Collaborators

• SerenaGroup, Inc.
• Anacapa Technologies Inc

Investigators

• Principal Investigator: Thomas E Serena, MD,FACS, Serena Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SerenaGroup, Inc.
• ClinicalTrials.gov Identifier: NCT04320628
• Other Study ID Numbers: ANTISEPTIC1
• First Posted: Mar 25, 2020
• Last Update Posted: Mar 14, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Wounds and Injuries; Anti-Infective Agents, Local

Study Results

No Results Posted as of Mar 14, 2022