Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances

NCT ID: NCT04218110

Last Updated: 2021-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 329 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-11
• Study Completion Date: 2020-03-31

Brief Summary

Comparative study of antimicrobial effectiveness evaluation of of 26ml Project X, 10.5ml 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.

Conditions

Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic

Intervention Type: DRUG

Application of antiseptic drug to the inguinal area of the subjects

Project X 10.5ml

3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.

Group Type: EXPERIMENTAL

Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic

Intervention Type: DRUG

Application of antiseptic drug to the inguinal area of the subjects

Project X 5.1ml

3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 10.5ml volume. Single use.

Group Type: EXPERIMENTAL

Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic

Intervention Type: DRUG

Application of antiseptic drug to the inguinal area of the subjects

Prevantics Maxi Swabstick

3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within pre-saturated applicator. 5.1ml volume. Single use.

Group Type: ACTIVE_COMPARATOR

Prevantics 3.15 % / 70 % Swabstick

Intervention Type: DRUG

Application of antiseptic drug to the inguinal area of the subjects

Interventions

Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic

Application of antiseptic drug to the inguinal area of the subjects

Intervention Type: DRUG

Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic

Application of antiseptic drug to the inguinal area of the subjects

Intervention Type: DRUG

Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic

Application of antiseptic drug to the inguinal area of the subjects

Intervention Type: DRUG

Prevantics 3.15 % / 70 % Swabstick

Application of antiseptic drug to the inguinal area of the subjects

Intervention Type: DRUG

Other Intervention Names

Project X 26ml; Project X 10.5ml; Project X 5.1ml; Prevantics Maxi Swabstick

Eligibility Criteria

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

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

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

3. Wear fabric softener, bug repellent or UV-treated clothing during the 14-day washout conditioning period and during the test period

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 Treatment Day baseline sample collection

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

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 Treatment Day, and throughout the test period

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Professional Disposables International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rozalia Olsavszky, MD

Role: PRINCIPAL_INVESTIGATOR

EUROFINS EVIC PRODUCT TESTING ROMANIA S.R.L

Locations

Eurofins EVIC

Bucharest, , Romania

Countries

Romania

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ER19/232

Identifier Type: -

Identifier Source: org_study_id