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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

More Details

Status
Terminated
Sponsor
University of Alabama at Birmingham

Study Contact

Notice

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