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

NCT04218110 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ER19/232
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 1

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

Keywords

Preventative

Outcome Measures

Primary Outcomes (1)

• Change in Bacterial Microflora in the Inguinal Area

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

  10 minutes

Secondary Outcomes (1)

• Change in Bacterial Microflora in the Inguinal Area

  30 seconds

Study Arms (4)

Project X 26ml

EXPERIMENTAL

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: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic

Project X 10.5ml

EXPERIMENTAL

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.

Drug: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic

Project X 5.1ml

EXPERIMENTAL

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.

Drug: Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic

Prevantics Maxi Swabstick

ACTIVE COMPARATOR

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

Drug: Prevantics 3.15 % / 70 % Swabstick

Interventions

Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic DRUG

Application of antiseptic drug to the inguinal area of the subjects

Also known as: Project X 26ml

Project X 26ml

Prevantics 3.15 % / 70 % Swabstick DRUG

Application of antiseptic drug to the inguinal area of the subjects

Also known as: Prevantics Maxi Swabstick

Prevantics Maxi Swabstick

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female at least 18 years of age and of any race
• In good general health
• Read, understand and sign the Informed Consent Form (ICF)
• 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)
• 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

You may not qualify if:

• 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
• Exposure of the test sites to strong detergents, solvents, or other irritants during the 14-day washout conditioning period and during the test period
• Wear fabric softener, bug repellent or UV-treated clothing during the 14-day washout conditioning period and during the test period
• 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
• 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
• 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
• 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)
• Pregnancy, plans to become pregnant within the washout and test periods of the study, or nursing a child
• Any tattoos or scars within 2" (5.08 cm) of the test sites
• Dermatoses, cuts, lesions, active skin rashes, or breaks or other skin disorders within 6" on or around the test sites
• 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
• Showering, bathing, or swimming within the 72-hour period prior to sampling for Treatment Day, and throughout the test period
• Participation in another clinical study in the past 30 days or current participation in another clinical study at time of signing informed consent
• Any medical condition or use of any medications that, in the opinion of the PI, should preclude participation
• Unwillingness to fulfill the performance requirements of the study.

Sponsors & Collaborators

• Professional Disposables International, Inc.: lead

Study Sites (1)

Eurofins EVIC

Bucharest, 040256, Romania

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

2-Propanol

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals

Results Point of Contact

• Title: Commercial Manager
• Organization: Eurofins EVIC

luciachirita@eurofins.com

+40 213357090

Study Officials

• Rozalia Olsavszky, MD

  EUROFINS EVIC PRODUCT TESTING ROMANIA S.R.L

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Samples are blinded to the Microbiology group, participant, sponsor (1 of 2) and statistician
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 6, 2020
• Study Start: February 11, 2020
• Primary Completion: March 10, 2020
• Study Completion: March 31, 2020
• Last Updated: October 22, 2021
• Results First Posted: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)