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

• Sponsor: Professional Disposables International, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03861780
• Collaborator: (none)
• Enrollment: 152
• Location: 1
• Arms: 3
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 71.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Bacteria Microflora Reduction	Drug: Project X 26ml; Drug: Project X 5.1ml; Drug: Prevantics Maxi Swabstick	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Samples are blinded to the participant and technical team
• Primary Purpose: Prevention
• Official Title: Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation
• Actual Study Start Date: Apr 2, 2019
• Actual Primary Completion Date: Jun 6, 2019
• Actual Study Completion Date: Jun 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Project X 26ml 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use.	Drug: Project X 26ml; Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Experimental: Project X 5.1ml 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.	Drug: Project X 5.1ml; Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Active Comparator: Prevantics Maxi Swabstick 3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use.	Drug: Prevantics Maxi Swabstick; Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Outcome Measures

Primary Outcome Measures

1. Change in Bacterial Microflora on the Inguinal Area [30 seconds]

   Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

2. Change in Bacterial Microflora on the Inguinal Area [10 minutes]

   Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

3. Change in Bacterial Microflora on the Inguinal Area [6 hours]

   Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

4. Change in Bacterial Microflora on the Abdomen Area [30 seconds]

   Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

5. Change in Bacterial Microflora on the Abdomen Area [10 minutes]

   Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

6. Change in Bacterial Microflora on the Abdomen Area [6 hours]

   Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bioscience Laboratories Inc	Bozeman	Montana	United States	59718

Sponsors and Collaborators

• Professional Disposables International, Inc.

Investigators

• Principal Investigator: Collette Duley, BioScience Laboratories, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 5, 2019

More Information

Publications

None provided.

• Responsible Party: Professional Disposables International, Inc.
• ClinicalTrials.gov Identifier: NCT03861780
• Other Study ID Numbers: 1810480-103
• First Posted: Mar 4, 2019
• Last Update Posted: Oct 22, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Pre-assignment Detail	152 subjects were consented, randomized into the study, treated with test product and completed the study. Each subject is able to receive 2 test products (1 on each side of their body).

Arm/Group Title	Project X 26ml	Project X 5.1ml	Prevantics Maxi Swabstick
Arm/Group Description	3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	3.15% w/v CHG / 70% v/v IPA. Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Period Title: Overall Study
STARTED	51	50	51
COMPLETED	51	50	51
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Project X 26ml	Project X 5.1ml	Prevantics Maxi Swabstick	Total
Arm/Group Description	3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	3.15% w/v CHG / 70% v/v IPA contained within a saturated at use applicator. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	3.15% w/v CHG / 70% v/v IPA. Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	Total of all reporting groups
Overall Participants	51	50	51	152
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	42.1	43.4	44.7	43.4
Sex: Female, Male (Count of Participants)
Female	22 43.1%	28 56%	28 54.9%	78 51.3%
Male	29 56.9%	22 44%	23 45.1%	74 48.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	38 74.5%	40 80%	40 78.4%	118 77.6%
Not Hispanic or Latino	7 13.7%	5 10%	4 7.8%	16 10.5%
Unknown or Not Reported	6 11.8%	5 10%	7 13.7%	18 11.8%

Outcome Measures

1. Primary Outcome

Title	Change in Bacterial Microflora on the Inguinal Area
Description	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Time Frame	30 seconds

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Project X 26ml	Project X 5.1ml	Prevantics Maxi Swabstick
Arm/Group Description	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	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. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Measure Participants	30	29	27
Measure evaluable sites	59	58	53
Mean (Standard Deviation) [log10 CFU]	-3.7 (1.4)	-3.1 (1.3)	-3.5 (1.4)

2. Primary Outcome

Title	Change in Bacterial Microflora on the Inguinal Area
Description	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Project X 26ml	Project X 5.1ml	Prevantics Maxi Swabstick
Arm/Group Description	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	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. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Measure Participants	29	29	27
Measure evaluable sites	58	58	53
Mean (Standard Deviation) [log10 CFU]	-3.5 (1.2)	-3.2 (1.5)	-3.3 (1.6)

3. Primary Outcome

Title	Change in Bacterial Microflora on the Inguinal Area
Description	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Project X 26ml	Project X 5.1ml	Prevantics Maxi Swabstick
Arm/Group Description	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	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. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Measure Participants	30	29	27
Measure evaluable sites	59	58	53
Mean (Standard Deviation) [log10 CFU]	-3.8 (1.3)	-3.6 (1.5)	-3.4 (1.4)

4. Primary Outcome

Title	Change in Bacterial Microflora on the Abdomen Area
Description	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Time Frame	30 seconds

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Project X 26ml	Project X 5.1ml	Prevantics Maxi Swabstick
Arm/Group Description	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	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. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Measure Participants	25	29	29
Measure evaluable sites	50	57	57
Mean (Standard Deviation) [log10 CFU]	-3.2 (1.1)	-2.9 (1.1)	-2.8 (1.1)

5. Primary Outcome

Title	Change in Bacterial Microflora on the Abdomen Area
Description	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Project X 26ml	Project X 5.1ml	Prevantics Maxi Swabstick
Arm/Group Description	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	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. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Measure Participants	25	29	29
Measure evaluable sites	50	57	57
Mean (Standard Deviation) [log10 CFU]	-3.0 (1.2)	-2.9 (1.1)	-2.9 (1.0)

6. Primary Outcome

Title	Change in Bacterial Microflora on the Abdomen Area
Description	Bacterial microflora (log10) will be measured via cup scrub method administration of the intervention
Time Frame	6 hours

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Project X 26ml	Project X 5.1ml	Prevantics Maxi Swabstick
Arm/Group Description	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	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. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Measure Participants	26	29	29
Measure evaluable sites	51	58	57
Mean (Standard Deviation) [log10 CFU]	-2.9 (1.0)	-3.0 (1.0)	-2.7 (1.0)

Adverse Events

Time Frame	2 months
Arm/Group Title	Project X 26 mL		Project X 5.1 mL		Prevantics Maxi Swabstick
Arm/Group Description	3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects		3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 5.1 ml volume. Single use. Project X 5.1 ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects		3.15% w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) Swabstick. Single use. Application of antiseptic drug to inguinal and abdomen areas of the subjects
All Cause Mortality
	Project X 26 mL		Project X 5.1 mL		Prevantics Maxi Swabstick
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/50 (0%)		0/51 (0%)
Serious Adverse Events
	Project X 26 mL		Project X 5.1 mL		Prevantics Maxi Swabstick
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/50 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Project X 26 mL		Project X 5.1 mL		Prevantics Maxi Swabstick
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/51 (2%)		0/50 (0%)		0/51 (0%)
Skin and subcutaneous tissue disorders
Treatment Related AE	1/51 (2%)		0/50 (0%)		0/51 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.