Bacteria Microflora ReductionPhase 3NCT03861780

Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation

A Phase 3 study testing Project X 26ml, Project X 5.1ml and Prevantics Maxi Swabstick in people with Bacteria Microflora Reduction, run by Professional Disposables International, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Comparative Study of Antimicrobial Effectiveness Evaluation of 26ml Project X, 5.1ml Project X and Prevantics Maxi Swabstick following ASTM E1173 - Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations, ASTM International, West Conshohocken, Pennsylvania, 2015 Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Bacteria Microflora Reduction
What is being tested?: Project X 26ml, Project X 5.1ml and Prevantics Maxi Swabstick
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 1 siteUnited States
Study dates: 2 Apr 2019to 6 Jun 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects may be of either sex, at least 18 years of age, and of any race.
Subjects must be able to read and understand English.
Subjects must have read and signed an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products prior to participating in the study, all located in the separate Informed Consent documents.
Subjects must be in good general health and have no medical diagnosis of a physical condition, such as a current or recent severe illness, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an organ transplant, mitral valve prolapse with heart murmur, fibromyalgia, ulcerative colitis, Crohn's disease, an immunocompromised condition such as AIDS (or HIV positive), lupus, or medicated multiple sclerosis.
Subjects will have test sites on the skin of the abdomen and/or inguinal free of injury and in good condition (no active skin rashes, excessive freckling, moles, scratches, breaks in the skin, etc.) and have no currently active skin diseases or skin conditions (for example, contact dermatitis, psoriasis or eczema) that may compromise subject safety or study integrity.
Subjects must have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders. Subjects with tattoos, scars, active skin rashes, or breaks in the skin of test sites, skin blemishes, such as dry scabs or warts, may be admitted at the discretion of the Principal Investigator, Subinvestigators, or Consulting Physicians.

Who cannot join

Known allergies to vinyl, latex (rubber), alcohols, metals, tapes or adhesives, inks, sunscreens, deodorants, laundry detergents, topically applied fragrances, cleansers, or to common antibacterial agents found in soaps or lotions, particularly chlorhexidine gluconate or ethanol.
Have experienced hives (raised welts) as a reaction to anything that contacted the skin.
Use of systemic or topical antibiotic medications during the 14-day pre-test period through completion of testing on the single test day.
Use of systemic or topical steroids, other than for contraception, hormone therapy, post-menopausal indications, during the 14-day pre-test period through completion of testing on the single test day. This includes steroid medications used to treat asthma. Note: topically applied hormonal steroids used for post-menopausal reasons must not get on the test sites.
Any type of port (or portacath) or Peripherally Inserted Central Catheter (PICC).
Pregnancy, plans to become pregnant or impregnate a sexual partner within the pre-test and test period of the study, or nursing a child. Female subjects must have a negative urine pregnancy test documented before treatment with test materials.
Current participation or participation in a clinical study in the past 14 days.
Any medical condition or use of any medications that, in the opinion of the Principal Investigator or consulting physicians, would preclude participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bioscience Laboratories Inc
Bozeman, Montana, 59718

Other trials in United States

About this study

Conditions: Bacteria Microflora Reduction
Being tested: Project X 26ml, Project X 5.1ml, Prevantics Maxi Swabstick

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Project X 26mlDrug
Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Project X 5.1mlDrug
Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Prevantics Maxi SwabstickDrug
Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Study groups in NCT03861780
Study group	Role	What they receive
Project X 26ml	Experimental	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Receives: Drug: Project X 26ml
Project X 5.1ml	Experimental	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1ml volume. Single use. Receives: Drug: Project X 5.1ml
Prevantics Maxi Swabstick	Active comparator	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Receives: Drug: Prevantics Maxi Swabstick

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Bacterial Microflora on the Inguinal Area
Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Measured: 30 seconds
Change in Bacterial Microflora on the Inguinal Area
Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Measured: 10 minutes
Change in Bacterial Microflora on the Inguinal Area
Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Measured: 6 hours
Change in Bacterial Microflora on the Abdomen Area
Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Measured: 30 seconds
Change in Bacterial Microflora on the Abdomen Area
Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Measured: 10 minutes
Change in Bacterial Microflora on the Abdomen Area
Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 20196 Jun 2019

First posted4 Mar 2019
Study start2 Apr 2019
Primary completion6 Jun 2019
Study completion6 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bacteria Microflora ReductionStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03861780
Sponsor's protocol ID: 1810480-103
Status last verified: Oct 2021
First submitted: 1 Mar 2019
Last updated: 22 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation
ClinicalTrials.gov ID: NCT03861780
Acronym / sponsor ID: 1810480-103
Conditions: Bacteria Microflora Reduction
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: Professional Disposables International, Inc.Industry (pharma, biotech, devices)
Study start: 2 Apr 2019 (actual)
Primary completion: 6 Jun 2019 (actual)
Study completion: 6 Jun 2019 (actual)
First posted: 4 Mar 2019 (actual)
Results: Posted 22 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Project X 26ml	Experimental	Drug: Project X 26ml3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use.
Project X 5.1ml	Experimental	Drug: Project X 5.1ml3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1ml volume. Single use.
Prevantics Maxi Swabstick	Active comparator	Drug: Prevantics Maxi Swabstick3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects may be of either sex, at least 18 years of age, and of any race.
Subjects must be able to read and understand English.
Subjects must have read and signed an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products prior to participating in the study, all located in the separate Informed Consent documents.
Subjects must be in good general health and have no medical diagnosis of a physical condition, such as a current or recent severe illness, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an organ transplant, mitral valve prolapse with heart murmur, fibromyalgia, ulcerative colitis, Crohn's disease, an immunocompromised condition such as AIDS (or HIV positive), lupus, or medicated multiple sclerosis.
Subjects will have test sites on the skin of the abdomen and/or inguinal free of injury and in good condition (no active skin rashes, excessive freckling, moles, scratches, breaks in the skin, etc.) and have no currently active skin diseases or skin conditions (for example, contact dermatitis, psoriasis or eczema) that may compromise subject safety or study integrity.

Key exclusion criteria (8 listed)

Known allergies to vinyl, latex (rubber), alcohols, metals, tapes or adhesives, inks, sunscreens, deodorants, laundry detergents, topically applied fragrances, cleansers, or to common antibacterial agents found in soaps or lotions, particularly chlorhexidine gluconate or ethanol.
Have experienced hives (raised welts) as a reaction to anything that contacted the skin.
Use of systemic or topical antibiotic medications during the 14-day pre-test period through completion of testing on the single test day.
Use of systemic or topical steroids, other than for contraception, hormone therapy, post-menopausal indications, during the 14-day pre-test period through completion of testing on the single test day. This includes steroid medications used to treat asthma. Note: topically applied hormonal steroids used for post-menopausal reasons must not get on the test sites.
Any type of port (or portacath) or Peripherally Inserted Central Catheter (PICC).

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
Project X 26mlApplication of antiseptic drug to the inguinal and abdomen areas of the subjects	Drug	Project X 26ml
Project X 5.1mlApplication of antiseptic drug to the inguinal and abdomen areas of the subjects	Drug	Project X 5.1ml
Prevantics Maxi SwabstickApplication of antiseptic drug to the inguinal and abdomen areas of the subjects	Drug	Prevantics Maxi Swabstick

Primary outcome

Change in Bacterial Microflora on the Inguinal Area
Time frame: 30 seconds
Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Change in Bacterial Microflora on the Inguinal Area
Time frame: 10 minutes
Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Change in Bacterial Microflora on the Inguinal Area
Time frame: 6 hours
Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Change in Bacterial Microflora on the Abdomen Area
Time frame: 30 seconds
Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Change in Bacterial Microflora on the Abdomen Area
Time frame: 10 minutes
Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Change in Bacterial Microflora on the Abdomen Area
Time frame: 6 hours
Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

Results and safety

Results posted to the registry on 22 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Project X 26ml	51	51
Project X 5.1ml	50	50
Prevantics Maxi Swabstick	51	51

Primary outcome: Change in Bacterial Microflora on the Inguinal Area

Time frame: 30 seconds. Mean (Standard Deviation). Unit: log10 CFU

Measure	Project X 26ml n = 30	Project X 5.1ml n = 29	Prevantics Maxi Swabstick n = 27
Value	-3.7 (1.4)	-3.1 (1.3)	-3.5 (1.4)

Population analysed: The overall number of participants analyzed represents the modified intent to treat (mITT) data set. The Participant Flow was is based on the intent to treat (ITT) dataset. Additionally, each subject is able to receive 2 test products (1 on each side of their body).

Primary outcome: Change in Bacterial Microflora on the Inguinal Area

Time frame: 10 minutes. Mean (Standard Deviation). Unit: log10 CFU

Measure	Project X 26ml n = 29	Project X 5.1ml n = 29	Prevantics Maxi Swabstick n = 27
Value	-3.5 (1.2)	-3.2 (1.5)	-3.3 (1.6)

Primary outcome: Change in Bacterial Microflora on the Inguinal Area

Time frame: 6 hours. Mean (Standard Deviation). Unit: log10 CFU

Measure	Project X 26ml n = 30	Project X 5.1ml n = 29	Prevantics Maxi Swabstick n = 27
Value	-3.8 (1.3)	-3.6 (1.5)	-3.4 (1.4)

Primary outcome: Change in Bacterial Microflora on the Abdomen Area

Time frame: 30 seconds. Mean (Standard Deviation). Unit: log10 CFU

Measure	Project X 26ml n = 25	Project X 5.1ml n = 29	Prevantics Maxi Swabstick n = 29
Value	-3.2 (1.1)	-2.9 (1.1)	-2.8 (1.1)

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Project X 26 mL	0 of 51 (0%)	1 of 51 (2%)	0 of 51
Project X 5.1 mL	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Prevantics Maxi Swabstick	0 of 51 (0%)	0 of 51 (0%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Collette Duley principal investigator

BioScience Laboratories, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 8 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 22 Oct 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Bacterial Microflora on the Inguinal Area (time frame: 30 seconds). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03861780.

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 22 Oct 2021.