Chronic WoundsNCT04320628
Randomized Double-Blind Controlled Clinical Trial
A study testing AnaSept® and NSS in people with Chronic Wounds and Acute Wounds, run by SerenaGroup, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Wounds, Acute Wounds
- What is being tested?
- AnaSept® and NSS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2020to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Serena Group Research Institute
Pittsburgh, Pennsylvania, 15222
About this study
Official title: Randomized Double-Blind Controlled Clinical Trial Comparing Sodium Hypochlorite Antiseptic to Normal Saline in Reducing Bioburden in Wounds
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.
Read the 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
- Being tested
- AnaSept®, NSS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnaSept®Device
Also called ANTISEPTIC
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.
NSSOther
NSS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: NSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
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.
Measured: 4 weeks
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".
Measured: 4 weeks
Adverse Events
The difference in adverse events between subjects treated with NaOCl vs, NSS
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start20 May 2020
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- AnaSept® AnaSept® Antimicrobial Skin and Wound Cleanser is a clear liquid consisting of 0.057% sodium hypochlorite (NaOCl) in an isotonic saline.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Collaborators
- Anacapa Technologies, Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas E Serena, MD,FACS, Principal investigator, Serena Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320628
- Sponsor's protocol ID
- ANTISEPTIC1
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2020
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Controlled Clinical Trial Comparing Sodium Hypochlorite Antiseptic to Normal Saline in Reducing Bioburden in Wounds
- ClinicalTrials.gov ID
- NCT04320628
- Acronym / sponsor ID
- ANTISEPTIC1
- Conditions
- Chronic Wounds, Acute Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Collaborators
- Anacapa Technologies, Inc.
- Study start
- 20 May 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- AnaSept® AnaSept® Antimicrobial Skin and Wound Cleanser is a clear liquid consisting of 0.057% sodium hypochlorite (NaOCl) in an isotonic saline.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: AnaSept®Target ulcer cleansed with NaOCl. After cleansing the wound a second MiX is performed. The subject is given a four-week supply of NaOCl. |
| Control | Placebo comparator | Other: NSSTarget ulcer cleansed with NSS. After cleansing the wound a second MiX is performed. The subject is given a four-week supply of NSS. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnaSept®Also: ANTISEPTICAnaSept® 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. | Device | Experimental |
| NSSNSS | Other | Control |
Primary outcome
Reduction in bacterial bioburden
Time frame: 4 weeks
The reduction in bacterial bioburden as determined by the MolecuLight Procedure (MiX) between normal saline (NSS) and sodium hypochlorite (NaOCl) wound washing.
3 secondary outcomes
Healing rate
Time frame: 4 weeks
Pain Score (PEG)
Time frame: 4 weeks
Adverse Events
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No. No plan to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas E Serena, MD,FACS principal investigator
Serena Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AnaSept® and NSS in people with Chronic Wounds and Acute Wounds, run by SerenaGroup, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in bacterial bioburden (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.