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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03861780

Enrollment

152

Registered

2019-03-04

Start date

2019-04-02

Completion date

2019-06-06

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

Bacteria Microflora Reduction

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

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

* 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.

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

Countries

United States

Participant flow

Pre-assignment details

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).

Participants by arm

Arm	Count
Project X 26ml 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	51
Project X 5.1ml 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	50
Prevantics Maxi Swabstick 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	51
Total	152

Baseline characteristics

Characteristic	Project X 26ml	Project X 5.1ml	Prevantics Maxi Swabstick	Total
Age, Continuous	42.1 years	43.4 years	44.7 years	43.4 years
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants	40 Participants	40 Participants	118 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants	5 Participants	4 Participants	16 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants	5 Participants	7 Participants	18 Participants
Sex: Female, Male Female	22 Participants	28 Participants	28 Participants	78 Participants
Sex: Female, Male Male	29 Participants	22 Participants	23 Participants	74 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 51	0 / 50	0 / 51
other Total, other adverse events	1 / 51	0 / 50	0 / 51
serious Total, serious adverse events	0 / 51	0 / 50	0 / 51