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

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Phase 3
Locations
Romania
Study Type
Interventional
Intervention
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic
Prevantics 3.15 % / 70 % Swabstick
Sponsored by
Professional Disposables International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Preventative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Eurofins EVIC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Project X 26ml

Project X 10.5ml

Project X 5.1ml

Prevantics Maxi Swabstick

Arm Description

3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use.

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.

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.

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

Outcomes

Primary Outcome Measures

Change in Bacterial Microflora in the Inguinal Area
Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention

Secondary Outcome Measures

Change in Bacterial Microflora in the Inguinal Area
Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention

Full Information

First Posted
December 30, 2019
Last Updated
October 4, 2021
Sponsor
Professional Disposables International, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04218110
Brief Title
Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances
Official Title
Preoperative Skin Preparation Study Following ASTM E1173 Methods to Evaluate the Antimicrobial Capabilities of Four Test Substances
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Professional Disposables International, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Preventative

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Samples are blinded to the Microbiology group, participant, sponsor (1 of 2) and statistician
Allocation
Randomized
Enrollment
329 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Project X 26ml
Arm Type
Experimental
Arm Description
3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within a saturated at use applicator. 26ml volume. Single use.
Arm Title
Project X 10.5ml
Arm Type
Experimental
Arm Description
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.
Arm Title
Project X 5.1ml
Arm Type
Experimental
Arm Description
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.
Arm Title
Prevantics Maxi Swabstick
Arm Type
Active Comparator
Arm Description
3.15% w/v CHG (chlorhexidine gluconate) /70% v/v IPA (isopropyl alcohol) contained within pre-saturated applicator. 5.1ml volume. Single use.
Intervention Type
Drug
Intervention Name(s)
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic
Other Intervention Name(s)
Project X 26ml
Intervention Description
Application of antiseptic drug to the inguinal area of the subjects
Intervention Type
Drug
Intervention Name(s)
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic
Other Intervention Name(s)
Project X 10.5ml
Intervention Description
Application of antiseptic drug to the inguinal area of the subjects
Intervention Type
Drug
Intervention Name(s)
Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic
Other Intervention Name(s)
Project X 5.1ml
Intervention Description
Application of antiseptic drug to the inguinal area of the subjects
Intervention Type
Drug
Intervention Name(s)
Prevantics 3.15 % / 70 % Swabstick
Other Intervention Name(s)
Prevantics Maxi Swabstick
Intervention Description
Application of antiseptic drug to the inguinal area of the subjects
Primary Outcome Measure Information:
Title
Change in Bacterial Microflora in the Inguinal Area
Description
Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Change in Bacterial Microflora in the Inguinal Area
Description
Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention
Time Frame
30 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rozalia Olsavszky, MD
Organizational Affiliation
EUROFINS EVIC PRODUCT TESTING ROMANIA S.R.L
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurofins EVIC
City
Bucharest
ZIP/Postal Code
040256
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No

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

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