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

Phase 4

Terminated

• Conditions: Surgical Site Infection
• Interventions: Other: Theraworx Bath Wipes; Drug: Chlorhexidine Gluconate 2% Wipe

• Registration Number: NCT03401749
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-17
• Study Start: 2018-11-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Results First Submitted: 2022-02-06
• Results First Submitted QC: 2022-03-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-01
• Results First Posted: 2022-04-04
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

• Adult patient between ages 18-64
• Scheduled and deemed healthy enough to undergo orthopaedic surgery
• Willing and able to comply with protocol

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Exclusion Criteria

• Clinical signs of infection
• Contraindication to CHG or Theraworx
• Previous allergic reaction to CHG or Theraworx
• Surgeon's Discretion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Theraworx Group	Theraworx Bath Wipes	Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery.
CHG Group	Chlorhexidine Gluconate 2% Wipe	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Developed a Surgical Site Infection	Within 1 year of Surgery	Clinical development of a surgical site infection in the postoperative period.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Compliant With the Requirement of Their Study Group	Day before and day of surgery	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.

Trial Locations

Locations (1)

UAB Highlands Hospital; 🇺🇸 Birmingham, Alabama, United States