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

Surgical Site Infection Clinical Trial

Official title:

Efficacy of Preadmission Theraworx Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03401749
• Other study ID #: IRB-300000508
• Status: Terminated
• Phase: Phase 4
• Start date: November 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 203
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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.

Locations

Country	Name	City	State
United States	UAB Highlands Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Developed a Surgical Site Infection	Clinical development of a surgical site infection in the postoperative period.	Within 1 year of Surgery
Secondary	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.	Day before and day of surgery