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Funding issues, poor recruiting and compliance of the patients.
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Intervention: This study will involve three different study arms with different interventions prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus chlorhexidine wipes
Study Design: Single center RCT
Sample Size: 500 patients, aged 18+
Objectives: Primary Objectives:
Secondary Objectives:
Expected Results: We expect no statistically significant difference in peri-operative cultures or surgical site infection rates between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Usual preadmission surgery instructions (shower the night before). | |
| Theraworx Group | Experimental | Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery. |
|
| CHG Group | Experimental | Usual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine Gluconate 2% Wipe | Drug | Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Developed a Surgical Site Infection | Clinical development of a surgical site infection in the postoperative period. | Within 1 year of Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Compliant With the Requirement of Their Study Group | Survey on patient's ability to follow the study guidelines. For example, if the patient was placed in the Theraworx study group, did they properly follow the instructions to shower and use the Theraworx skin wipe system the night before surgery. | Day before and day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ashish shah, md | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Highlands Hospital | Birmingham | Alabama | 35205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Usual preadmission surgery instructions (shower the night before). |
| FG001 | Theraworx Group | Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery. Theraworx Bath Wipes: Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6. |
| FG002 | CHG Group | Usual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery. Chlorhexidine Gluconate 2% Wipe: Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Usual preadmission surgery instructions (shower the night before). |
| BG001 | Theraworx Group | Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery. Theraworx Bath Wipes: Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6. |
| 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 | Number of Participants That Developed a Surgical Site Infection | Clinical development of a surgical site infection in the postoperative period. | Posted | Count of Participants | Participants | Within 1 year of Surgery |
|
Adverse events (i.e surgical site infection) were recorded if they occurred within one year from the date of surgery.
Upon completion of this study, we retrospectively observed the occurrence of any adverse event in our patient population utilizing our electronic medical record. . Using the standardized clinical trials definition of "adverse event" we carefully determined the rate at which these events occurred.
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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 | Control Group | Usual preadmission surgery instructions (shower the night before). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbated Congestive Heart Failure | Cardiac disorders | Systematic Assessment | Patient with history of CHF suffered from acute exacerbation in within the 1 year postoperative time frame. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical Site Infection | Infections and infestations | Systematic Assessment | This is the same measure as the primary outcome "number of participants who developed a surgical site infection" |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashish Shah | University of Alabama at Birmingham | 205-930-6722 | ashishshah@uabmc.edu |
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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 | Apr 23, 2020 | Jan 28, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2022 | Feb 6, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 23, 2018 | Jan 28, 2022 | ICF_002.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 |
|---|---|
| C010882 | chlorhexidine gluconate |
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| Theraworx Bath Wipes | Other | Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6. |
|
|
| BG002 | CHG Group | Usual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery. Chlorhexidine Gluconate 2% Wipe: Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Average BMI of each cohort. | Mean | Standard Deviation | kg/m^2 |
|
| Tobacco Use | Participants that recorded previous or current use of tobacco products. | Count of Participants | Participants |
|
| Presence of Diabetes | Number of participants with a diagnosis of diabetes. | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Presence of Rheumatoid Arthritis | Number of participants with a diagnosis of Rheumatoid Arthritis | Count of Participants | Participants |
|
| Presence of Preoperative Neuropathy | Number of participants who have a diagnosis of neuropathy affecting the lower limb. | Count of Participants | Participants |
|
| OG002 | CHG Group | Usual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery. Chlorhexidine Gluconate 2% Wipe: Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery. |
|
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| Secondary | Number of Patients Compliant With the Requirement of Their Study Group | Survey on patient's ability to follow the study guidelines. For example, if the patient was placed in the Theraworx study group, did they properly follow the instructions to shower and use the Theraworx skin wipe system the night before surgery. | Posted | Count of Participants | Participants | Day before and day of surgery |
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| 2 |
| 59 |
| 2 |
| 59 |
| 2 |
| 59 |
| EG001 | Theraworx Group | Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery. Theraworx Bath Wipes: Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6. | 1 | 67 | 1 | 67 | 1 | 67 |
| EG002 | CHG Group | Usual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery. Chlorhexidine Gluconate 2% Wipe: Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery. | 1 | 77 | 1 | 77 | 3 | 77 |
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| Carotid Pseudo-aneurysm | Vascular disorders | Systematic Assessment | Number of patients who suffered from a carotid pseudo-aneurysm in the 1 year postoperative time frame. |
|
| Pulmonary Embolism | Blood and lymphatic system disorders | Systematic Assessment | Number of patients who developed a pulmonary embolism within 1 year from their date of surgery. |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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