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

• Status: Terminated
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Allantoin; Chlorhexidine; Chlorhexidine gluconate

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