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Study discontinued due to data quality issues.
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| Name | Class |
|---|---|
| 3M | INDUSTRY |
The purpose of this study is to evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%. On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M CHG/IPA Prep Colorless | Experimental | Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
|
| 3M CHG/IPA Prep Tint | Experimental | Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
|
| ChloraPrep Hi-Lite Orange | Active Comparator | Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
|
| Normal Saline | Placebo Comparator | Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M CHG/IPA Prep Colorless | Drug | Apply topically. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate | On the abdominal region a responder was a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours. On the inguinal region a responder was a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours. | baseline, 10 minute post-product application and 6 hour post-product application |
| Skin Flora Baseline for Abdominal and Inguinal Regions | Log10/cm2 baseline skin flora for abdominal and inguinal regions | Baseline |
| Skin Flora Recovery Post-treatment | Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions | 10 minutes and 6 hours post-treatment |
| Reduction of Skin Flora Post-treatment | Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours | Baseline, 10 minutes and 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as Assessed by Skin Irritation Scores | Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event. | Baseline |
| Safety as Assessed by Skin Irritation Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert R McCormack, BS | BioScience Laboratories, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioScience Laboratories, Inc. | Bozeman | Montana | 59718 | United States |
This is a randomized, paired comparison design where each subject received 2 of the planned treatments, 1 on the left side and one on the right. Each subject provided 2 abdomen test sites, left & right and/or 2 inguen test sites, left & right.
161 subjects were randomized for the abdomen region & 162 subjects randomized for the inguen region, resulting in 171 subjects providing 646 applications of test products on 2 anatomical regions.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3M CHG/IPA Prep Colorless Abdominal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. |
| FG001 | 3M CHG/IPA Prep Tint Abdominal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Tint: Apply topically. |
| FG002 | ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically. |
| FG003 | Normal Saline Abdominal Region | 0.9% normal saline with applicator Normal Saline: Apply topically. |
| FG004 | 3M CHG/IPA Prep Colorless Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. |
| FG005 | 3M CHG/IPA Prep Tint Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. |
| FG006 | ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically. |
| FG007 | Normal Saline Inguinal Region | 0.9% normal saline with applicator Normal Saline: Apply topically. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects with average screening day baseline counts of > or equal to 3.00 log10 CFU/cm2 bilaterally on the abdominal region and/or > or equal to 5.00 log10 CFU/cm2 bilaterally on the inguinal region were to be included in the efficacy analysis. However, due to early study termination the primary efficacy endpoint analysis was not performed. The 171 subjects who provided 646 test sites on skin for product application on the 2 anatomical regions were included in the safety analyses.
| ID | Title | Description |
|---|---|---|
| BG000 | 3M CHG/IPA Prep Colorless Abdominal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. |
| BG001 | 3M CHG/IPA Prep Tint Abdominal Region |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Responder Rate | On the abdominal region a responder was a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours. On the inguinal region a responder was a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours. | This study was discontinued prematurely due to technical and data quality issues. In agreement with the FDA no efficacy analysis was conducted. Thus, the efficacy objective of the study could not be evaluated. | Posted | baseline, 10 minute post-product application and 6 hour post-product application |
|
Adverse events (AEs) were collected on treatment day (1 day), thus all AEs by definition would be treatment-emergent.
On Treatment Day, prior to collection of the baseline, 10-minute, and 6-hour post-prep samples, the skin in each test area will be evaluated for indications of skin irritation (dryness, edema, erythema, rash), based on the Skin Irritation Rating Scale: 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
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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 | 3M CHG/IPA Prep Tint Abdominal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Tint: Apply topically. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan E. Paulson | 3M Health Care | 651-736-6583 | jepaulson@mmm.com |
Not provided
| ID | Term |
|---|---|
| D019840 | 2-Propanol |
| D002864 | Chromogranins |
| C010882 | chlorhexidine gluconate |
| D000431 | Ethanol |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D020005 | Propanols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D009419 | Nerve Tissue Proteins |
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| 3M CHG/IPA Prep Tint | Drug | Apply topically. |
|
|
| ChloraPrep | Drug | Apply topically. |
|
|
| Saline | Drug | Apply topically. |
|
|
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event. |
| 10 minutes post-treatment |
| Safety as Assessed by Skin Irritation Scores | Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event. | 6 hours post-treatment |
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Tint: Apply topically.
| BG002 | ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically. |
| BG003 | Normal Saline Abdominal Region | 0.9% normal saline with applicator Normal Saline: Apply topically. |
| BG004 | 3M CHG/IPA Prep Colorless Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. |
| BG005 | 3M CHG/IPA Prep Tint Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. |
| BG006 | ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically. |
| BG007 | Normal Saline Inguinal Region | 0.9% normal saline with applicator Normal Saline: Apply topically. |
| BG008 | Total | Total of all reporting groups |
| test sites on skin |
|
| test sites on skin |
| test sites on skin |
|
| Sex/Gender, Customized | Number | test sites on skin | test sites on skin |
|
| Race/Ethnicity, Customized | Number | test sites on skin | test sites on skin |
|
| OG001 |
| 3M CHG/IPA Prep Tint Abdominal Region |
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Tint: Apply topically. |
| OG002 | ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically. |
| OG003 | Normal Saline Abdominal Region | 0.9% normal saline with applicator Normal Saline: Apply topically. |
| OG004 | 3M CHG/IPA Prep Colorless Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. |
| OG005 | 3M CHG/IPA Prep Tint Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. |
| OG006 | ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically. |
| OG007 | Normal Saline Inguinal Region | 0.9% normal saline with applicator Normal Saline: Apply topically. |
|
| Primary | Skin Flora Baseline for Abdominal and Inguinal Regions | Log10/cm2 baseline skin flora for abdominal and inguinal regions | This study was discontinued prematurely due to technical and data quality issues. In agreement with the FDA no efficacy analysis was conducted. Thus, the efficacy objective of the study could not be evaluated. | Posted | Baseline |
|
|
| Primary | Skin Flora Recovery Post-treatment | Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions | This study was discontinued prematurely due to technical and data quality issues. In agreement with the FDA no efficacy analysis was conducted. Thus, the efficacy objective of the study could not be evaluated. | Posted | 10 minutes and 6 hours post-treatment |
|
|
| Primary | Reduction of Skin Flora Post-treatment | Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours | This study was discontinued prematurely due to technical and data quality issues. In agreement with the FDA no efficacy analysis was conducted. Thus, the efficacy objective of the study could not be evaluated. | Posted | Baseline, 10 minutes and 6 hours |
|
|
| Secondary | Safety as Assessed by Skin Irritation Scores | Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event. | # of sites treated (met inclusion/exclusion criteria including screening day baseline counts) | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Safety as Assessed by Skin Irritation Scores | Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event. | # of sites treated (met inclusion/exclusion criteria including screening day baseline counts | Posted | Count of Participants | Participants | 10 minutes post-treatment |
|
|
|
| Secondary | Safety as Assessed by Skin Irritation Scores | Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event. | # sites treated (met inclusion/exclusion criteria including screening day baseline counts) | Posted | Count of Participants | Participants | 6 hours post-treatment |
|
|
|
| 0 |
| 93 |
| 0 |
| 93 |
| 0 |
| 93 |
| EG001 | 3M CHG/IPA Prep Colorless Abdominal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. | 0 | 101 | 0 | 101 | 0 | 101 |
| EG002 | ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically. | 0 | 96 | 0 | 96 | 0 | 96 |
| EG003 | Normal Saline Abdominal Region | 0.9% normal saline with applicator Normal Saline: Apply topically. | 0 | 32 | 0 | 32 | 0 | 32 |
| EG004 | 3M CHG/IPA Prep Colorless Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. | 0 | 97 | 0 | 97 | 0 | 97 |
| EG005 | 3M CHG/IPA Prep Tint Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator 3M CHG/IPA Prep Colorless: Apply topically. | 0 | 99 | 0 | 99 | 0 | 99 |
| EG006 | ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically. | 0 | 97 | 0 | 97 | 0 | 97 |
| EG007 | Normal Saline Inguinal Region | 0.9% normal saline with applicator Normal Saline: Apply topically. | 0 | 31 | 0 | 31 | 0 | 31 |
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| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Dryness-Mild (1) |
|
| Dryness-Moderate (2) |
|
| Dryness-Severe (3) |
|
| Edema-No reaction (0) |
|
| Edema-Mild (1) |
|
| Edema-Moderate (2) |
|
| Edema-Severe (3) |
|
| Erythema- No reaction (0) |
|
| Erythema-Mild (1) |
|
| Erythema-Moderate (2) |
|
| Erythema-Severe (3) |
|
| Rash-No Reaction (0) |
|
| Rash-Mild (1) |
|
| Rash-Moderate (2) |
|
| Rash-Severe (3) |
|
| Dryness-Mild (1) |
|
| Dryness-Moderate (2) |
|
| Dryness-Severe (3) |
|
| Edema-No Reaction (0) |
|
| Edema-Mild (1) |
|
| Edema-Moderate (2) |
|
| Edema-Severe (3) |
|
| Erythema-No Reaction (0) |
|
| Erythema-Mild (1) |
|
| Erythema-Moderate (2) |
|
| Erythema-Severe (3) |
|
| Rash-No Reaction (0) |
|
| Rash-Mild (1) |
|
| Rash-Moderate (2) |
|
| Rash-Severe (3) |
|
| Dryness-Mild (1) |
|
| Dryness-Moderate (2) |
|
| Dryness-Severe (3) |
|
| Edema-No Reaction (0) |
|
| Edema-Mild (1) |
|
| Edema-Moderate (2) |
|
| Edema-Severe (3) |
|
| Erythema-No Reaction (0) |
|
| Erythema-Mild (1) |
|
| Erythema-Moderate (2) |
|
| Erythema-Severe (3) |
|
| Rash-No Reaction (0) |
|
| Rash-Mild (1) |
|
| Rash-Moderate (2) |
|
| Rash-Severe (3) |
|