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



Status:Recruiting
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - 64
Updated:12/8/2018
Start Date:November 1, 2018
End Date:January 1, 2021
Contact:Ashish B Shah, M.D.
Email:ashishshah@uabmc.edu
Phone:205-930-8339

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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
We found this trial at
1
site
UAB Highlands Hospital
Birmingham, Alabama 35294
Phone: 205-975-2671
?
mi
from
Birmingham, AL
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