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

Phase 4TerminatedNCT03401749

University of Alabama at Birmingham203 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

203

Conditions

Surgical Site Infection

Interventions

Theraworx Bath WipesOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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