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This study will evaluate a new topical skin antiseptic perioperative preparation and the standard of care to determine efficacy on the rates of surgical site infections of surgical patients. Safety will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 70% Isopropyl Alcohol novel preoperative skin antiseptic | Experimental | 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation |
|
| 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antiseptic | Active Comparator | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 70% v/v Isopropyl Alcohol Surgical Solution | Drug | Patient preoperative skin preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Site Infection Occurrence | The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections. | Within 30 days after surgery |
| Allergic Reaction and Skin Irritation | The primary safety objective is to determine the rates of skin irritation or allergic reactions attributed to each drug product and all other adverse events. | Within 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup Analysis of Rates of Surgical Site Infections | Surgical site infection rates by different infection types classified as superficial incisional infection, deep incisional infection, or organ-space infection. | Within 30 days after surgery |
| Subgroup Analysis of Rates of Surgical Site Infections |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph P Hart, MD, FACS, DFSVS | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MCW/FH | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation 70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation |
| FG001 | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation 70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation |
| BG001 | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Surgical Site Infection Occurrence | The primary objective is to demonstrate efficacy in surgical use through the rate of surgical site infections. | Posted | Count of Participants | Participants | Within 30 days after surgery |
|
AE's reported from time of enrollment through follow up (30 days post op), up to 51 days ( up to 21 days for screening).
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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 | 70% Isopropyl Alcohol Novel Preoperative Skin Antiseptic | 70% v/v Isopropyl Alcohol novel preoperative skin antisepsis preparation 70% v/v Isopropyl Alcohol Surgical Solution: Patient preoperative skin preparation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Distress | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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This was a pilot study of surgical patients, the majority of which had significant comorbidities with several AEs reported in more than one patient across the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Reg Affairs | Zurex Pharma, Inc. | 608.203.9090 | customercare@zurexpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2021 | Jan 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2022 | Jan 24, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol | Drug | Patient preoperative skin preparation |
|
|
Surgical site infection rates by type of surgery including clean (class I wound) or clean-contaminated (class II wounds) surgeries |
| Within 30 days after surgery |
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | Allergic Reaction and Skin Irritation | The primary safety objective is to determine the rates of skin irritation or allergic reactions attributed to each drug product and all other adverse events. | Posted | Count of Participants | Participants | Within 30 days after surgery |
|
|
|
| Secondary | Subgroup Analysis of Rates of Surgical Site Infections | Surgical site infection rates by different infection types classified as superficial incisional infection, deep incisional infection, or organ-space infection. | Posted | Count of Participants | Participants | Within 30 days after surgery |
|
|
|
| Secondary | Subgroup Analysis of Rates of Surgical Site Infections | Surgical site infection rates by type of surgery including clean (class I wound) or clean-contaminated (class II wounds) surgeries | Secondary outcome categorizes the results of the primary outcome - surgical site infections. The study only resulted in observation of 1 surgical site infection in one of the two interventions. Therefore, the novel prep secondary outcome results in a zero value reported. | Posted | Count of Participants | Participants | Within 30 days after surgery |
|
|
|
| 0 |
| 25 |
| 10 |
| 25 |
| 0 |
| 25 |
| EG001 | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol Preoperative Skin Antiseptic | 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol preoperative skin antisepsis preparation 2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol: Patient preoperative skin preparation | 1 | 26 | 11 | 26 | 0 | 26 |
| Pulmonary Distress | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Renal Distress | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute Blood Loss Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Heart Failure Exacerbation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lactic Acidosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Outcome fatal, 2 days post op. |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Outcome fatal, 2 days post op. |
|
| Hepatic Failure | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment | Outcome fatal, 2 days post op. |
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| Acute Circulatory Failure | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment | Outcome fatal, 2 days post op. |
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| Cardiogenic Shock | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Outcome fatal, 2 days post op. |
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| Occlusion of Renal Artery | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebral Hyperperfusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hypervolemic Shock | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Altered Mental State | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Endoleak | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| TIA | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Surgical Site Infection | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| organ-space infection |
|
| No surgical site infection present |
|