Trial Outcomes & Findings for Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients (NCT NCT03401749)
NCT ID: NCT03401749
Last Updated: 2022-05-02
Results Overview
Clinical development of a surgical site infection in the postoperative period.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
203 participants
Primary outcome timeframe
Within 1 year of Surgery
Results posted on
2022-05-02
Participant Flow
Participant milestones
| Measure |
Control Group
Usual preadmission surgery instructions (shower the night before).
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
59
|
67
|
77
|
|
Overall Study
COMPLETED
|
39
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
20
|
16
|
26
|
Reasons for withdrawal
| Measure |
Control Group
Usual preadmission surgery instructions (shower the night before).
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
20
|
16
|
26
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=59 Participants
Usual preadmission surgery instructions (shower the night before).
|
Theraworx Group
n=67 Participants
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.
|
CHG Group
n=77 Participants
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
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=59 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=77 Participants
|
0 Participants
n=203 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=59 Participants
|
59 Participants
n=67 Participants
|
59 Participants
n=77 Participants
|
160 Participants
n=203 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=59 Participants
|
8 Participants
n=67 Participants
|
18 Participants
n=77 Participants
|
43 Participants
n=203 Participants
|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 14.92 • n=59 Participants
|
49.71 years
STANDARD_DEVIATION 14.93 • n=67 Participants
|
49.68 years
STANDARD_DEVIATION 14.95 • n=77 Participants
|
51.66 years
STANDARD_DEVIATION 14.94 • n=203 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=59 Participants
|
44 Participants
n=67 Participants
|
52 Participants
n=77 Participants
|
136 Participants
n=203 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=59 Participants
|
23 Participants
n=67 Participants
|
25 Participants
n=77 Participants
|
67 Participants
n=203 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
59 participants
n=59 Participants
|
67 participants
n=67 Participants
|
77 participants
n=77 Participants
|
203 participants
n=203 Participants
|
|
Body Mass Index
|
32.46 kg/m^2
STANDARD_DEVIATION 7.58 • n=59 Participants
|
33.61 kg/m^2
STANDARD_DEVIATION 7.92 • n=67 Participants
|
32.8 kg/m^2
STANDARD_DEVIATION 7.59 • n=77 Participants
|
33.15 kg/m^2
STANDARD_DEVIATION 7.86 • n=203 Participants
|
|
Tobacco Use
|
19 Participants
n=59 Participants
|
24 Participants
n=67 Participants
|
28 Participants
n=77 Participants
|
71 Participants
n=203 Participants
|
|
Presence of Diabetes
|
10 Participants
n=59 Participants
|
14 Participants
n=67 Participants
|
14 Participants
n=77 Participants
|
38 Participants
n=203 Participants
|
|
Hypertension
|
38 Participants
n=59 Participants
|
37 Participants
n=67 Participants
|
43 Participants
n=77 Participants
|
118 Participants
n=203 Participants
|
|
Presence of Rheumatoid Arthritis
|
6 Participants
n=59 Participants
|
0 Participants
n=67 Participants
|
8 Participants
n=77 Participants
|
14 Participants
n=203 Participants
|
|
Presence of Preoperative Neuropathy
|
7 Participants
n=59 Participants
|
7 Participants
n=67 Participants
|
8 Participants
n=77 Participants
|
22 Participants
n=203 Participants
|
PRIMARY outcome
Timeframe: Within 1 year of SurgeryClinical development of a surgical site infection in the postoperative period.
Outcome measures
| Measure |
Control Group
n=59 Participants
Usual preadmission surgery instructions (shower the night before).
|
Theraworx Group
n=67 Participants
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.
|
CHG Group
n=77 Participants
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.
|
|---|---|---|---|
|
Number of Participants That Developed a Surgical Site Infection
|
2 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day before and day of surgerySurvey 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.
Outcome measures
| Measure |
Control Group
n=59 Participants
Usual preadmission surgery instructions (shower the night before).
|
Theraworx Group
n=67 Participants
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.
|
CHG Group
n=77 Participants
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.
|
|---|---|---|---|
|
Number of Patients Compliant With the Requirement of Their Study Group
|
45 Participants
|
66 Participants
|
67 Participants
|
Adverse Events
Control Group
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Theraworx Group
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
CHG Group
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Control Group
n=59 participants at risk
Usual preadmission surgery instructions (shower the night before).
|
Theraworx Group
n=67 participants at risk
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.
|
CHG Group
n=77 participants at risk
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.
|
|---|---|---|---|
|
Cardiac disorders
Exacerbated Congestive Heart Failure
|
3.4%
2/59 • Number of events 2 • 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.
|
0.00%
0/67 • 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.
|
0.00%
0/77 • 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.
|
|
Vascular disorders
Carotid Pseudo-aneurysm
|
0.00%
0/59 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
0.00%
0/77 • 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.
|
|
Blood and lymphatic system disorders
Pulmonary Embolism
|
0.00%
0/59 • 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.
|
0.00%
0/67 • 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.
|
1.3%
1/77 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Control Group
n=59 participants at risk
Usual preadmission surgery instructions (shower the night before).
|
Theraworx Group
n=67 participants at risk
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.
|
CHG Group
n=77 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
Surgical Site Infection
|
3.4%
2/59 • Number of events 2 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
3.9%
3/77 • Number of events 3 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place