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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,
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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 swabstick. 26ml volume. Single use. |
|
| Project X 5.1ml | Experimental | 3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use. |
|
| Prevantics Maxi Swabstick | Active Comparator | 3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Project X 26ml | Drug | Application of antiseptic drug to the inguinal and abdomen areas of the subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bacterial Microflora on the Inguinal Area | Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention | 30 seconds |
| Change in Bacterial Microflora on the Inguinal Area | Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention | 10 minutes |
| Change in Bacterial Microflora on the Inguinal Area | Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention | 6 hours |
| Change in Bacterial Microflora on the Abdomen | Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention | 30 seconds |
| Change in Bacterial Microflora on the Abdomen | Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention | 10 minutes |
| Change in Bacterial Microflora on the Abdomen | Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention | 6 hours |
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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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170 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 / 70% v/v IPA contained within a saturated at use swabstick. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects |
| FG001 | 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. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects |
| FG002 | Prevantics Maxi Swabstick | 3.15 % w/v CHG / 70% v/v IPA. Swabstick. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 swabstick. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects |
| BG001 | Project X 5.1ml |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 on the Inguinal Area | Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention | The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. 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 |
|
4 months
visual assessments of skin irritation and reporting of irritation by subjects
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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 swabstick. 26ml volume. Single use. Project X 26ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Commercial Manager | Eurofins EVIC | 40 213357090 | luciachirita@eurofins.com |
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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 | Jan 14, 2019 | Jun 1, 2021 | Prot_SAP_000.pdf |
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Samples are blinded to the participant and technical team.
| Project X 5.1ml | Drug | Application of antiseptic drug to the inguinal and abdomen areas of the subjects |
|
| Prevantics Maxi Swabstick | Drug | Application of antiseptic drug to the inguinal and abdomen areas of the subjects |
|
3.15 % w/v CHG / 70% v/v IPA contained within a saturated at use swabstick. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects |
| BG002 | Prevantics Maxi Swabstick | 3.15 % w/v CHG / 70% v/v IPA. Swabstick. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Project X 5.1ml |
3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol) contained within a saturated at use swabstick. 5.1ml volume. Single use. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects |
| OG002 | Prevantics Maxi Swabstick | 3.15 % w/v CHG (chlorhexidine gluconate) / 70% v/v IPA (isopropyl alcohol). Swabstick. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects |
|
|
| Primary | Change in Bacterial Microflora on the Inguinal Area | Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention | The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. 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 |
|
|
|
| Primary | Change in Bacterial Microflora on the Inguinal Area | Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention | The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body). | Posted | Mean | Standard Deviation | log10 CFU | 6 hours | evaluable sites | evaluable sites |
|
|
|
| Primary | Change in Bacterial Microflora on the Abdomen | Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention | The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. 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 |
|
|
|
| Primary | Change in Bacterial Microflora on the Abdomen | Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention | The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. 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 |
|
|
|
| Primary | Change in Bacterial Microflora on the Abdomen | Bacterial microflora (log10) will be measured via cup scrub method after administration of the intervention | The overall number of participants analyzed above represents the per protocol data set while the participant flow data represents the treated set. Additionally, each subject is able to receive 2 test products (1 on each side of their body). | Posted | Mean | Standard Deviation | log10 CFU | 6 hours | evaluable sites | evaluable sites |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | 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. Project X 5.1ml: Application of antiseptic drug to the inguinal and abdomen areas of the subjects | 0 | 56 | 0 | 56 | 0 | 56 |
| EG002 | Prevantics Maxi Swabstick | 3.15 % w/v CHG / 70% v/v IPA. Swabstick. 5.1ml volume. Single use. Prevantics Maxi Swabstick: Application of antiseptic drug to the inguinal and abdomen areas of the subjects | 0 | 57 | 0 | 57 | 0 | 57 |
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