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Trial record 34 of 10547 for:    Anti-Infective Agents AND Bacterial

Comparative Study of Antimicrobial Effectiveness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03817580
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Professional Disposables International, Inc.

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,

Condition or disease Intervention/treatment Phase
Bacterial Microflora Reduction Drug: Project X 26ml Drug: Project X 5.1ml Drug: Prevantics Maxi Swabstick Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Masking Description: Samples are blinded to the participant and technical team.
Primary Purpose: Prevention
Official Title: Comparative Study of Antimicrobial Effectiveness Evaluation of 26 ml Project X, 5.1 ml Project X and Prevantics® Maxi Swabstick Following ASTM E1173
Actual Study Start Date : February 18, 2019
Actual Primary Completion Date : June 4, 2019
Actual Study Completion Date : June 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Project X 26ml
3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 26ml volume. Single use.
Drug: Project X 26ml
Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Experimental: 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.
Drug: Project X 5.1ml
Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Active Comparator: Prevantics Maxi Swabstick
3.15 % w/v CHG / 70% v/v IPA. Swabstick. 5.1ml volume. Single use.
Drug: Prevantics Maxi Swabstick
Application of antiseptic drug to the inguinal and abdomen areas of the subjects




Primary Outcome Measures :
  1. Change in bacterial microflora on the inguinal area [ Time Frame: 30 seconds ]
    Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

  2. Change in bacterial microflora on the inguinal area [ Time Frame: 10 minutes ]
    Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

  3. Change in bacterial microflora on the inguinal area [ Time Frame: 6 hours ]
    Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

  4. Change in bacterial microflora on the abdomen [ Time Frame: 30 seconds ]
    Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

  5. Change in bacterial microflora on the abdomen [ Time Frame: 10 minutes ]
    Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention

  6. Change in bacterial microflora on the abdomen [ Time Frame: 6 hours ]
    Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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 CFU/cm2 bilaterally from the skin of the abdomen, and 5.00 log10 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817580


Locations
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Romania
Eurofins EVIC
Bucharest, Romania, 040256
Sponsors and Collaborators
Professional Disposables International, Inc.
Investigators
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Principal Investigator: Rozalia Olsavszky, MD EUROFINS EVIC PRODUCT TESTING ROMANIA S.R.L

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Responsible Party: Professional Disposables International, Inc.
ClinicalTrials.gov Identifier: NCT03817580     History of Changes
Other Study ID Numbers: ER18/282
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents