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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic | Drug | Application of antiseptic drug to the inguinal area of the subjects |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bacterial Microflora in the Inguinal Area | Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention | 30 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rozalia Olsavszky, MD | EUROFINS EVIC PRODUCT TESTING ROMANIA S.R.L | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins EVIC | Bucharest | 040256 | Romania |
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328 individual subjects were consented, screened, treated and completed the study. Each subject is able to receive 2 test products (1 on each side of their body).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2019 |
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Samples are blinded to the Microbiology group, participant, sponsor (1 of 2) and statistician
| Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic | Drug | Application of antiseptic drug to the inguinal area of the subjects |
|
|
| Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic | Drug | Application of antiseptic drug to the inguinal area of the subjects |
|
|
| Prevantics 3.15 % / 70 % Swabstick | 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. Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects |
| FG002 | 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. Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects |
| FG003 | 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. Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline Participant data is based on the Intent to Treat (ITT) data set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Project X 26ml | 3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use. Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects |
| BG001 | Project X 10.5ml | 3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use. Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects |
| BG002 | Project X 5.1ml | 3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use. Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects |
| BG003 | Prevantics Maxi Swabstick | 3.15% w/v CHG/70% v/v IPA contained within pre-saturated applicator. 5.1ml volume. Single use. Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Bacterial Microflora in the Inguinal Area | Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention | The Overall Number of Participants Analyzed represents the modified intent to treat (mITT) dataset where the Participant Flow represents the intent to treat (ITT) dataset. Additionally, each subject is able to receive 2 test products (1 on each side of their body). | Posted | Mean | Standard Deviation | log10 CFU | 10 minutes | evaluable sites | evaluable sites |
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| ||||||||||||||||||||||||||||||||
| Secondary | Change in Bacterial Microflora in the Inguinal Area | Bacterial microflora (log10) will be measured via cup scrub method following the administration of the intervention | The Overall Number of Participants Analyzed represents the modified intent to treat (mITT) dataset where the Participant Flow represents the intent to treat (ITT) dataset. Additionally, each subject is able to receive 2 test products (1 on each side of their body). | Posted | Mean | Standard Deviation | log10 CFU | 30 seconds | evaluable sites | evaluable sites |
|
1.5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Project X 26ml | 3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 26ml volume. Single use. Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects | 0 | 82 | 0 | 82 | 0 | 82 |
| EG001 | Project X 10.5ml | 3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use. Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects | 0 | 81 | 0 | 81 | 0 | 81 |
| EG002 | Project X 5.1ml | 3.15% w/v CHG/70% v/v IPA contained within a saturated at use applicator. 10.5ml volume. Single use. Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic: Application of antiseptic drug to the inguinal area of the subjects | 0 | 83 | 0 | 83 | 0 | 83 |
| EG003 | Prevantics Maxi Swabstick | 3.15% w/v CHG/70% v/v IPA contained within pre-saturated applicator. 5.1ml volume. Single use. Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects | 0 | 82 | 0 | 82 | 0 | 82 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Event | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Unexpected, non-serious adverse event |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Commercial Manager | Eurofins EVIC | +40 213357090 | luciachirita@eurofins.com |
| Jun 1, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019840 | 2-Propanol |
| ID | Term |
|---|---|
| D020005 | Propanols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| American Indian/Alaska Native |
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| Black/African American |
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| Asian |
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| Subject Refused to Disclose |
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| Other/Combination of 2 or more races (specify) |
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| evaluable sites |
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| OG003 | 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. Prevantics 3.15 % / 70 % Swabstick: Application of antiseptic drug to the inguinal area of the subjects |
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