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The purpose of this study is to evaluate the safety and effectiveness of a topical antiseptic for preoperative skin preparation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comparator | Active Comparator | Chlorhexidine gluconate |
|
| experimental | Experimental | BDIP-0001 |
|
| placebo | Placebo Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine gluconate | Drug |
| ||
| N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Abdominal Site Responder Rates at 10 Minutes | Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a 2 log10/cm^2 CFU reduction were considered "responders," and individually treated groin sites with a 3 log10/cm^2 CFU reduction were considered "responders." | 10 min |
| Percentage of Abdominal Site Responder Rates at 6 Hours | Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a log10/cm^2 CFU reduction greater than or equal to 0 were considered responders. | 6 hours |
| Percentage of Groin Site Responder Rate at 6 Hours | Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a log10/cm^2 CFU reduction greater than or equal to 0 were considered responders. | 6 hours |
| Percentage of Groin Sites Responder Rates at 10 Minutes | Participants were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a 3 log10/cm^2 CFU reduction were considered "responders." | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Burroughs | Becton, Dickinson and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioScience Laboratories | Butte | Montana | 59701 | United States |
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Participants were only treated if they met baseline bacterial count criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated Participants | Participants were treated with 2 of 3 study products, Investigational Product (IP, 0.4% OCT cloth), Vehicle Control (VC, vehicle formulation cloth), and/or Active Control (AC, SAGE 2% CHG cloth), 1 on the left side of the body (abdomen and inguen received the same product) and 1 on the right (abdomen and inguen received the same product). Therefore, treatment groups are not discrete categories and cannot be described by treatment group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants were treated with 2 of 3 study products, Investigational Product (IP, 0.4% OCT cloth), Vehicle Control (VC, vehicle formulation cloth), and/or Active Control (AC, SAGE 2% CHG cloth), 1 on the left side of the body (abdomen and inguen received the same product) and 1 on the right (abdomen and groin received the same product). Therefore, treatment groups are not discrete categories and cannot be described by treatment group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treated Participants | Participants were treated with 2 of 3 study products, Investigational Product (IP, 0.4% OCT cloth), Vehicle Control (VC, vehicle formulation cloth), and/or Active Control (AC, SAGE 2% CHG cloth), 1 on the left side of the body (abdomen and inguen received the same product) and 1 on the right (abdomen and inguen received the same product). Therefore, treatment groups are not discrete categories and cannot be described by treatment group. |
| 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 | Percentage of Abdominal Site Responder Rates at 10 Minutes | Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a 2 log10/cm^2 CFU reduction were considered "responders," and individually treated groin sites with a 3 log10/cm^2 CFU reduction were considered "responders." | Number of individual sites that met treatment day bacterial requirements on the abdomen for analysis are IP = 48, AC = 48, VC = 19 | Posted | Mean | 95% Confidence Interval | percentage of abdomen sites | 10 min | Individual abdominal sites | Individual abdominal sites |
|
6 hours
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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 | All Participants | Participants were treated with 2 of 3 study products, Investigational Product (IP, 0.4% OCT cloth), Vehicle Control (VC, vehicle formulation cloth), and/or Active Control (AC, SAGE 2% CHG cloth), 1 on the left side of the body (abdomen and inguen received the same product) and 1 on the right (abdomen and inguen received the same product). Therefore, treatment groups are not discrete categories and cannot be described by treatment group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Zook | Becton Dickinson | 201-847-5351 | erin.zook@bd.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 | Sep 20, 2016 | Oct 28, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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| Drug |
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| Placebo | Drug |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Active Control | Active Control (AC) Sage 2% Chlorhexidine gluconate |
| OG002 | Vehicle Control | Vehicle Control (VC) |
|
|
| Primary | Percentage of Abdominal Site Responder Rates at 6 Hours | Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated abdomen sites with a log10/cm^2 CFU reduction greater than or equal to 0 were considered responders. | Number of abdomen sites passing treatment day bacterial requirements were analyzed for responder rates. The number of anatomical sites meeting treatment day bacterial requirements were IP = 48, AC = 48, VC = 19 for the abdomen. | Posted | Mean | 95% Confidence Interval | percentage of abdomen sites | 6 hours | Individual Abdomen sites | Individual Abdomen sites |
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|
|
| Primary | Percentage of Groin Site Responder Rate at 6 Hours | Individual anatomical sites were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a log10/cm^2 CFU reduction greater than or equal to 0 were considered responders. | Individual sites that met treatment day bacterial requirements were analyzed for responder rates. Number of sites passing treatment day bacterial requirements on the groin were IP = 51, AC = 51, and VC = 18. | Posted | Mean | 95% Confidence Interval | percentage of groin sites | 6 hours | Individual Groin Sites | Individual Groin Sites |
|
|
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| Primary | Percentage of Groin Sites Responder Rates at 10 Minutes | Participants were considered responders based on the standards set forth in the Food and Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation (FR 59:116, 17 June 94, pp. 31450-31452). Individually treated groin sites with a 3 log10/cm^2 CFU reduction were considered "responders." | Number of individually treated groin sites that passed treatment day bacterial requirements were IP = 51, AC = 51, and VC = 18. | Posted | Mean | 95% Confidence Interval | percentage of groin sites | 10 minutes | Individual Groin Sites | Individual Groin Sites |
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| 0 |
| 145 |
| 0 |
| 145 |
| 0 |
| 145 |
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