Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients

Study Overview
=================
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.

Official Title
-----------------
Efficacy of Preadmission Theraworx Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients: A Randomized Controlled Trial

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Drug: Chlorhexidine Gluconate 2% Wipe
* Other: Theraworx Bath Wipes


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Usual preadmission surgery instructions (shower the night before). | |
| Experimental: Theraworx Group<br>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<br>* 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.<br>* Other names: Theraworx;|
| Experimental: CHG Group<br>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<br>* Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |