Comparative Study of Antimicrobial Effectiveness

• Sponsor: Professional Disposables International, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03817580
• Collaborator: (none)
• Enrollment: 170
• Location: 1
• Arms: 3
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 48.8

Study Details

Study Description

Brief Summary

Comparative Study of Antimicrobial Effectiveness Evaluation of 26 ml 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, PA, 2015,

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 170 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: Comparative Study of Antimicrobial Effectiveness Evaluation of 26 ml Project X, 5.1 ml Project X and Prevantics® Maxi Swabstick Following ASTM E1173
• Actual Study Start Date: Feb 18, 2019
• Actual Primary Completion Date: Jun 4, 2019
• Actual Study Completion Date: Jun 4, 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 swabstick. 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 swabstick. 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. 5.1ml volume. 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 after 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 after 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 after administration of the intervention

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

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

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

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

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

   Bacterial microflora (log10) will be measured via cup scrub method after 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:

1. Male or female at least 18 years of age and of any race

2. In good general health

3. Read, understand and sign the Informed Consent Form (ICF)

4. If female of child-bearing potential, are willing to use an acceptable method of contraception to prevent pregnancy (i.e. oral contraceptive, intra-uterine device, diaphragm, condom, abstinence, bilateral tubal ligation, or are in a monogamous relationship with a partner who has had a vasectomy)

5. Female subjects of child-bearing potential, must have a negative Urine Pregnancy Test (UPT) on Treatment Day prior to any applications of the study products

6. Screening Day Baseline microbial counts are at least 3.11 colony forming units (CFU)/cm2 bilaterally from the skin of the abdomen, and 5.00 log10 colony forming units (CFU)/cm2 bilaterally from the skin of the groin (not applicable for Neutralization study)

Exclusion Criteria:

1. Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 14-day washout conditioning period and during the test period (7-day for Neutralization study)

2. Exposure of the test sites to strong detergents, solvents, or other irritants during the 14-day washout conditioning period and during the test period (7-day for Neutralization study)

3. Wear fabric softener, bug repellent or UV-treated clothing during the 14-day washout conditioning period and during the test period (7-day for Neutralization study)

4. Receive an irritation score of 1 (any redness, swelling, rash, or dryness present at any treatment area) for any individual skin condition prior to the Screening Day baseline or Treatment Day baseline sample collection or Neutralization study

5. Use of systemic or topical antibiotic medications, steroid medications (other than for hormonal contraception or post-menopausal reasons), or any other product known to affect the normal microbial flora of the skin during the 14-day washout conditioning period and during the test period (7-day for Neutralization study)

6. Known allergies or sensitivities to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly isopropyl alcohol or chlorhexidine gluconate

7. A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapses, congenital heart disease, internal prostheses, or any immunocompromised conditions such as AIDS (or HIV positive)

8. Pregnancy, plans to become pregnant within the washout and test periods of the study, or nursing a child

9. Any tattoos or scars within 2" (5.08 cm) of the test sites

10. Dermatoses, cuts, lesions, active skin rashes, or breaks or other skin disorders within 6" on or around the test sites

11. A currently active skin disease or inflammatory skin condition (for example, contact dermatitis) anywhere on the body that, in the opinion of the Consulting Physician or PI, would compromise subject safety or study integrity

12. Showering, bathing, or swimming within the 72-hour period prior to sampling for baseline screening, Treatment Day, and throughout the test period (not applicable for Neutralization study)

13. Participation in another clinical study in the past 30 days or current participation in another clinical study at time of signing informed consent

14. Any medical condition or use of any medications that, in the opinion of the PI, should preclude participation

15. Unwillingness to fulfill the performance requirements of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurofins EVIC	Bucharest		Romania	040256

Sponsors and Collaborators

• Professional Disposables International, Inc.

Investigators

• Principal Investigator: Rozalia Olsavszky, MD, EUROFINS EVIC PRODUCT TESTING ROMANIA S.R.L

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 14, 2019

More Information

Publications

None provided.

• Responsible Party: Professional Disposables International, Inc.
• ClinicalTrials.gov Identifier: NCT03817580
• Other Study ID Numbers: ER18/282
• First Posted: Jan 25, 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	170 individual subjects were consented, screened, treated 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 swabstick. 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 swabstick. 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. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Period Title: Overall Study
STARTED	57	56	57
COMPLETED	57	56	57
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 swabstick. 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 swabstick. 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. 5.1ml volume. 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	57	56	57	170
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	58.4	56.8	57.6	57.6
Sex/Gender, Customized (participants) [Number]
Female	46 80.7%	45 80.4%	46 80.7%	137 80.6%
Male	11 19.3%	11 19.6%	11 19.3%	33 19.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	57 100%	56 100%	57 100%	170 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

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 after administration of the intervention
Time Frame	30 seconds

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. 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 swabstick. 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 swabstick. 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. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Measure Participants	34	31	30
Measure evaluable sites	67	62	59
Mean (Standard Deviation) [log10 CFU]	-3.92 (1.42)	-3.69 (1.56)	-3.94 (1.60)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. 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 swabstick. 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 swabstick. 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. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Measure Participants	34	31	30
Measure evaluable sites	67	62	59
Mean (Standard Deviation) [log10 CFU]	-4.07 (1.62)	-4.04 (1.61)	-4.17 (1.57)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. 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 swabstick. 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 swabstick. 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. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Measure Participants	34	31	30
Measure evaluable sites	67	62	59
Mean (Standard Deviation) [log10 CFU]	-4.30 (1.43)	-4.57 (1.62)	-4.28 (1.53)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. 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 swabstick. 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 swabstick. 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. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Measure Participants	30	30	32
Measure evaluable sites	59	59	63
Mean (Standard Deviation) [log10 CFU]	-3.09 (0.76)	-2.95 (1.11)	-2.85 (1.08)

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. 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 swabstick. 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 swabstick. 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. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Measure Participants	30	30	32
Measure evaluable sites	59	59	63
Mean (Standard Deviation) [log10 CFU]	-3.15 (0.85)	-2.97 (1.06)	-3.01 (0.82)

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. 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 swabstick. 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 swabstick. 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. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
Measure Participants	30	30	32
Measure evaluable sites	59	59	63
Mean (Standard Deviation) [log10 CFU]	-3.19 (0.87)	-3.27 (0.95)	-3.18 (0.91)

Adverse Events

Time Frame	4 months
Adverse Event Reporting Description	visual assessments of skin irritation and reporting of irritation by subjects
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 swabstick. 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 swabstick. 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. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects
All Cause Mortality
	Project X 26ml		Project X 5.1ml		Prevantics Maxi Swabstick
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/56 (0%)		0/57 (0%)
Serious Adverse Events
	Project X 26ml		Project X 5.1ml		Prevantics Maxi Swabstick
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/56 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	Project X 26ml		Project X 5.1ml		Prevantics Maxi Swabstick
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/56 (0%)		0/57 (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.