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

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 4

Conditions: Surgical Site Infection

Treatments: Drug: Chlorhexidine Gluconate 2% Wipe; Other: Theraworx Bath Wipes

Study type: Interventional

Funder types: Other

Identifiers

NCT03401749

IRB-300000508

Details and patient eligibility

About

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.

Enrollment: 203 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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203 participants in 3 patient groups

Control Group

No Intervention group

Description:

Usual preadmission surgery instructions (shower the night before).

Theraworx Group

Experimental group

Description:

Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery.

Treatment:

Other: Theraworx Bath Wipes

CHG Group

Experimental group

Description:

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.

Treatment:

Drug: Chlorhexidine Gluconate 2% Wipe