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

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

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.

Study Overview

• Status: Terminated
• Conditions: Surgical Site Infection
• Intervention / Treatment: Other: Theraworx Bath Wipes; Drug: Chlorhexidine Gluconate 2% Wipe

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • UAB Highlands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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: Theraworx
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.

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: ashish shah, md, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: IRB-300000508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes