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

Primary Purpose

Surgical Site Infection

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine Gluconate 2% Wipe
Theraworx Bath Wipes
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • UAB Highlands Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

Theraworx Group

CHG Group

Arm Description

Usual preadmission surgery instructions (shower the night before).

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

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.

Outcomes

Primary Outcome Measures

Number of Participants That Developed a Surgical Site Infection
Clinical development of a surgical site infection in the postoperative period.

Secondary Outcome Measures

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.

Full Information

First Posted
January 10, 2018
Last Updated
April 1, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03401749
Brief Title
Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients
Official Title
Efficacy of Preadmission Theraworx Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Funding issues, poor recruiting and compliance of the patients.
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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: Monitor for safety and adverse effects. Evaluate for differences in peri-operative skin cultures between treatment groups; Compare surgical site infection rates between groups. Secondary Objectives: Assess for patient compliance for each different treatment arms. Measure patient satisfaction. Measure nurse satisfaction. Visual assessment of wound healing Expected Results: We expect no statistically significant difference in peri-operative cultures or surgical site infection rates between groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Usual preadmission surgery instructions (shower the night before).
Arm Title
Theraworx Group
Arm Type
Experimental
Arm Description
Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery.
Arm Title
CHG Group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine Gluconate 2% Wipe
Intervention Description
Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery.
Intervention Type
Other
Intervention Name(s)
Theraworx Bath Wipes
Other Intervention Name(s)
Theraworx
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants That Developed a Surgical Site Infection
Description
Clinical development of a surgical site infection in the postoperative period.
Time Frame
Within 1 year of Surgery
Secondary Outcome Measure Information:
Title
Number of Patients Compliant With the Requirement of Their Study Group
Description
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.
Time Frame
Day before and day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ashish shah, md
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Highlands Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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