NCT03401749

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2018-01-17
• Last updated: 2022-05-02
• Results posted: 2022-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study