Comparative Study of Antimicrobial Effectiveness

Comparative Study of Antimicrobial Effectiveness Evaluation of 26 ml Project X, 5.1 ml Project X and Prevantics® Maxi Swabstick Following ASTM E1173

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03817580

Enrollment

170

Registered

2019-01-25

Start date

2019-02-18

Completion date

2019-06-04

Last updated

2021-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Microflora Reduction

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,

Interventions

DRUGProject X 26ml

Application of antiseptic drug to the inguinal and abdomen areas of the subjects

DRUGProject X 5.1ml

Application of antiseptic drug to the inguinal and abdomen areas of the subjects

DRUGPrevantics Maxi Swabstick

Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Masking description

Samples are blinded to the participant and technical team.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Countries

Romania

Participant flow

Pre-assignment details

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).

Participants by arm

Arm	Count
Project X 26ml 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	57
Project X 5.1ml 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	56
Prevantics Maxi Swabstick 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	57
Total	170

Baseline characteristics

Characteristic	Project X 26ml	Project X 5.1ml	Prevantics Maxi Swabstick	Total
Age, Continuous	58.4 years	56.8 years	57.6 years	57.6 years
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants	56 Participants	57 Participants	170 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Sex/Gender, Customized Female	46 participants	45 participants	46 participants	137 participants
Sex/Gender, Customized Male	11 participants	11 participants	11 participants	33 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 57	0 / 56	0 / 57
other Total, other adverse events	0 / 57	0 / 56	0 / 57
serious Total, serious adverse events	0 / 57	0 / 56	0 / 57