Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients
Study Details
Study Description
Brief Summary
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:
-
Monitor for safety and adverse effects.
-
Evaluate for differences in peri-operative skin cultures between treatment groups;
-
Compare surgical site infection rates between groups.
Secondary Objectives:
-
Assess for patient compliance for each different treatment arms.
-
Measure patient satisfaction.
-
Measure nurse satisfaction.
-
Visual assessment of wound healing
Expected Results: We expect no statistically significant difference in peri-operative cultures or surgical site infection rates between groups.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: Control Group Usual preadmission surgery instructions (shower the night before). |
|
Experimental: 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. |
Other: 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.
Other Names:
|
Experimental: 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. |
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants That Developed a Surgical Site Infection [Within 1 year of Surgery]
Clinical development of a surgical site infection in the postoperative period.
Secondary Outcome Measures
- Number of Patients Compliant With the Requirement of Their Study Group [Day before and day of surgery]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult patient between ages 18-64
-
Scheduled and deemed healthy enough to undergo orthopaedic surgery
-
Willing and able to comply with protocol
Exclusion Criteria:
-
Clinical signs of infection
-
Contraindication to CHG or Theraworx
-
Previous allergic reaction to CHG or Theraworx
-
Surgeon's Discretion
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | UAB Highlands Hospital | Birmingham | Alabama | United States | 35205 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
- Principal Investigator: ashish shah, md, University of Alabama at Birmingham
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB-300000508
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Control Group | Theraworx Group | CHG Group |
---|---|---|---|
Arm/Group Description | Usual preadmission surgery instructions (shower the night before). | 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. | 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. |
Period Title: Overall Study | |||
STARTED | 59 | 67 | 77 |
COMPLETED | 39 | 51 | 51 |
NOT COMPLETED | 20 | 16 | 26 |
Baseline Characteristics
Arm/Group Title | Control Group | Theraworx Group | CHG Group | Total |
---|---|---|---|---|
Arm/Group Description | Usual preadmission surgery instructions (shower the night before). | 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. | 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. | Total of all reporting groups |
Overall Participants | 59 | 67 | 77 | 203 |
Age (Count of Participants) | ||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
42
71.2%
|
59
88.1%
|
59
76.6%
|
160
78.8%
|
>=65 years |
17
28.8%
|
8
11.9%
|
18
23.4%
|
43
21.2%
|
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
55.7
(14.92)
|
49.71
(14.93)
|
49.68
(14.95)
|
51.66
(14.94)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
40
67.8%
|
44
65.7%
|
52
67.5%
|
136
67%
|
Male |
19
32.2%
|
23
34.3%
|
25
32.5%
|
67
33%
|
Race and Ethnicity Not Collected (Count of Participants) | ||||
Count of Participants [Participants] |
0
0%
|
|||
Region of Enrollment (participants) [Number] | ||||
United States |
59
100%
|
67
100%
|
77
100%
|
203
100%
|
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [kg/m^2] |
32.46
(7.58)
|
33.61
(7.92)
|
32.8
(7.59)
|
33.15
(7.86)
|
Tobacco Use (Count of Participants) | ||||
Count of Participants [Participants] |
19
32.2%
|
24
35.8%
|
28
36.4%
|
71
35%
|
Presence of Diabetes (Count of Participants) | ||||
Count of Participants [Participants] |
10
16.9%
|
14
20.9%
|
14
18.2%
|
38
18.7%
|
Hypertension (Count of Participants) | ||||
Count of Participants [Participants] |
38
64.4%
|
37
55.2%
|
43
55.8%
|
118
58.1%
|
Presence of Rheumatoid Arthritis (Count of Participants) | ||||
Count of Participants [Participants] |
6
10.2%
|
0
0%
|
8
10.4%
|
14
6.9%
|
Presence of Preoperative Neuropathy (Count of Participants) | ||||
Count of Participants [Participants] |
7
11.9%
|
7
10.4%
|
8
10.4%
|
22
10.8%
|
Outcome Measures
Title | Number of Participants That Developed a Surgical Site Infection |
---|---|
Description | Clinical development of a surgical site infection in the postoperative period. |
Time Frame | Within 1 year of Surgery |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Control Group | Theraworx Group | CHG Group |
---|---|---|---|
Arm/Group Description | Usual preadmission surgery instructions (shower the night before). | 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. | 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. |
Measure Participants | 59 | 67 | 77 |
Count of Participants [Participants] |
2
3.4%
|
1
1.5%
|
3
3.9%
|
Title | Number of Patients Compliant With the Requirement of Their Study Group |
---|---|
Description | 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. |
Time Frame | Day before and day of surgery |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Control Group | Theraworx Group | CHG Group |
---|---|---|---|
Arm/Group Description | Usual preadmission surgery instructions (shower the night before). | 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. | 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. |
Measure Participants | 59 | 67 | 77 |
Count of Participants [Participants] |
45
76.3%
|
66
98.5%
|
67
87%
|
Adverse Events
Time Frame | Adverse events (i.e surgical site infection) were recorded if they occurred within one year from the date of surgery. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | 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. | |||||
Arm/Group Title | Control Group | Theraworx Group | CHG Group | |||
Arm/Group Description | Usual preadmission surgery instructions (shower the night before). | 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. | 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. | |||
All Cause Mortality |
||||||
Control Group | Theraworx Group | CHG Group | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/59 (3.4%) | 1/67 (1.5%) | 1/77 (1.3%) | |||
Serious Adverse Events |
||||||
Control Group | Theraworx Group | CHG Group | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/59 (3.4%) | 1/67 (1.5%) | 1/77 (1.3%) | |||
Blood and lymphatic system disorders | ||||||
Pulmonary Embolism | 0/59 (0%) | 0 | 0/67 (0%) | 0 | 1/77 (1.3%) | 1 |
Cardiac disorders | ||||||
Exacerbated Congestive Heart Failure | 2/59 (3.4%) | 2 | 0/67 (0%) | 0 | 0/77 (0%) | 0 |
Vascular disorders | ||||||
Carotid Pseudo-aneurysm | 0/59 (0%) | 0 | 1/67 (1.5%) | 1 | 0/77 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
Control Group | Theraworx Group | CHG Group | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/59 (3.4%) | 1/67 (1.5%) | 3/77 (3.9%) | |||
Infections and infestations | ||||||
Surgical Site Infection | 2/59 (3.4%) | 2 | 1/67 (1.5%) | 1 | 3/77 (3.9%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Ashish Shah |
---|---|
Organization | University of Alabama at Birmingham |
Phone | 205-930-6722 |
ashishshah@uabmc.edu |
- IRB-300000508