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

NCT03401749 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB-300000508
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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. 1.Monitor for safety and adverse effects.
2. 2.Evaluate for differences in peri-operative skin cultures between treatment groups;
3. 3.Compare surgical site infection rates between groups.
4. 4.Assess for patient compliance for each different treatment arms.
5. 5.Measure patient satisfaction.
6. 6.Measure nurse satisfaction.
7. 7.Visual assessment of wound healing

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Patients Compliant With the Requirement of Their Study Group

  Day before and day of surgery

Study Arms (3)

Control Group

NO INTERVENTION

Usual preadmission surgery instructions (shower the night before).

Theraworx Group

EXPERIMENTAL

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

Other: Theraworx Bath Wipes

CHG Group

EXPERIMENTAL

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.

Drug: Chlorhexidine Gluconate 2% Wipe

Interventions

Chlorhexidine Gluconate 2% Wipe DRUG

Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery.

CHG Group

Theraworx Bath Wipes OTHER

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.

Also known as: Theraworx

Theraworx Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Highlands Hospital

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ashish Shah
• Organization: University of Alabama at Birmingham

ashishshah@uabmc.edu

205-930-6722

Study Officials

• ashish shah, md

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Orthopaedics

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 17, 2018
• Study Start: November 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 2, 2022
• Results First Posted: April 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)