Surgical Site Infection
Conditions
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: 1. Monitor for safety and adverse effects. 2. Evaluate for differences in peri-operative skin cultures between treatment groups; 3. Compare surgical site infection rates between groups. Secondary Objectives: 1. Assess for patient compliance for each different treatment arms. 2. Measure patient satisfaction. 3. Measure nurse satisfaction. 4. Visual assessment of wound healing Expected Results: We expect no statistically significant difference in peri-operative cultures or surgical site infection rates between groups.
Interventions
Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery.
OTHERTheraworx 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Usual preadmission surgery instructions (shower the night before). | 59 |
| 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. | 67 |
| 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. | 77 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 20 | 16 | 26 |
Baseline characteristics
| Characteristic | CHG Group | Total | Control Group | Theraworx Group |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 43 Participants | 17 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 160 Participants | 42 Participants | 59 Participants |
| Age, Continuous | 49.68 years STANDARD_DEVIATION 14.95 | 51.66 years STANDARD_DEVIATION 14.94 | 55.7 years STANDARD_DEVIATION 14.92 | 49.71 years STANDARD_DEVIATION 14.93 |
| Body Mass Index | 32.8 kg/m^2 STANDARD_DEVIATION 7.59 | 33.15 kg/m^2 STANDARD_DEVIATION 7.86 | 32.46 kg/m^2 STANDARD_DEVIATION 7.58 | 33.61 kg/m^2 STANDARD_DEVIATION 7.92 |
| Hypertension | 43 Participants | 118 Participants | 38 Participants | 37 Participants |
| Presence of Diabetes | 14 Participants | 38 Participants | 10 Participants | 14 Participants |
| Presence of Preoperative Neuropathy | 8 Participants | 22 Participants | 7 Participants | 7 Participants |
| Presence of Rheumatoid Arthritis | 8 Participants | 14 Participants | 6 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Region of Enrollment United States | 77 participants | 203 participants | 59 participants | 67 participants |
| Sex: Female, Male Female | 52 Participants | 136 Participants | 40 Participants | 44 Participants |
| Sex: Female, Male Male | 25 Participants | 67 Participants | 19 Participants | 23 Participants |
| Tobacco Use | 28 Participants | 71 Participants | 19 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 59 | 1 / 67 | 1 / 77 |
| other Total, other adverse events | 2 / 59 | 1 / 67 | 3 / 77 |
| serious Total, serious adverse events | 2 / 59 | 1 / 67 | 1 / 77 |
Outcome results
Primary
Number of Participants That Developed a Surgical Site Infection
Clinical development of a surgical site infection in the postoperative period.
Time frame: Within 1 year of Surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants That Developed a Surgical Site Infection | 2 Participants |
| Theraworx Group | Number of Participants That Developed a Surgical Site Infection | 1 Participants |
| CHG Group | Number of Participants That Developed a Surgical Site Infection | 3 Participants |
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.
Time frame: Day before and day of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Patients Compliant With the Requirement of Their Study Group | 45 Participants |
| Theraworx Group | Number of Patients Compliant With the Requirement of Their Study Group | 66 Participants |
| CHG Group | Number of Patients Compliant With the Requirement of Their Study Group | 67 Participants |