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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Terminated
CT.gov ID
NCT03401749
Collaborator
(none)
203
1
3
25
8.1

Study Details

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:
  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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chlorhexidine Gluconate 2% Wipe
  • Other: Theraworx Bath Wipes
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
203 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Efficacy of Preadmission Theraworx Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients: A Randomized Controlled Trial
Actual Study Start Date :
Nov 1, 2018
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

Usual preadmission surgery instructions (shower the night before).

Experimental: Theraworx Group

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
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.
Other Names:
  • Theraworx
  • Experimental: CHG Group

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

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants That Developed a Surgical Site Infection [Within 1 year of Surgery]

      Clinical development of a surgical site infection in the postoperative period.

    Secondary Outcome Measures

    1. Number of Patients Compliant With the Requirement of Their Study Group [Day before and day of surgery]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UAB Highlands Hospital Birmingham Alabama United States 35205

    Sponsors and Collaborators

    • University of Alabama at Birmingham

    Investigators

    • Principal Investigator: ashish shah, md, University of Alabama at Birmingham

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Ashish Shah, Assistant Professor, Department of Orthopaedics, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT03401749
    Other Study ID Numbers:
    • IRB-300000508
    First Posted:
    Jan 17, 2018
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Control Group Theraworx Group CHG Group
    Arm/Group 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. 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. 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. 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.
    Period Title: Overall Study
    STARTED 59 67 77
    COMPLETED 39 51 51
    NOT COMPLETED 20 16 26

    Baseline Characteristics

    Arm/Group Title Control Group Theraworx Group CHG Group Total
    Arm/Group 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. 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. 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. 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. Total of all reporting groups
    Overall Participants 59 67 77 203
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    42
    71.2%
    59
    88.1%
    59
    76.6%
    160
    78.8%
    >=65 years
    17
    28.8%
    8
    11.9%
    18
    23.4%
    43
    21.2%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    55.7
    (14.92)
    49.71
    (14.93)
    49.68
    (14.95)
    51.66
    (14.94)
    Sex: Female, Male (Count of Participants)
    Female
    40
    67.8%
    44
    65.7%
    52
    67.5%
    136
    67%
    Male
    19
    32.2%
    23
    34.3%
    25
    32.5%
    67
    33%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    59
    100%
    67
    100%
    77
    100%
    203
    100%
    Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    32.46
    (7.58)
    33.61
    (7.92)
    32.8
    (7.59)
    33.15
    (7.86)
    Tobacco Use (Count of Participants)
    Count of Participants [Participants]
    19
    32.2%
    24
    35.8%
    28
    36.4%
    71
    35%
    Presence of Diabetes (Count of Participants)
    Count of Participants [Participants]
    10
    16.9%
    14
    20.9%
    14
    18.2%
    38
    18.7%
    Hypertension (Count of Participants)
    Count of Participants [Participants]
    38
    64.4%
    37
    55.2%
    43
    55.8%
    118
    58.1%
    Presence of Rheumatoid Arthritis (Count of Participants)
    Count of Participants [Participants]
    6
    10.2%
    0
    0%
    8
    10.4%
    14
    6.9%
    Presence of Preoperative Neuropathy (Count of Participants)
    Count of Participants [Participants]
    7
    11.9%
    7
    10.4%
    8
    10.4%
    22
    10.8%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Control Group Theraworx Group CHG Group
    Arm/Group 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. 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. 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. 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.
    Measure Participants 59 67 77
    Count of Participants [Participants]
    2
    3.4%
    1
    1.5%
    3
    3.9%
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Control Group Theraworx Group CHG Group
    Arm/Group 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. 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. 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. 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.
    Measure Participants 59 67 77
    Count of Participants [Participants]
    45
    76.3%
    66
    98.5%
    67
    87%

    Adverse Events

    Time Frame Adverse events (i.e surgical site infection) were recorded if they occurred within one year from the date of surgery.
    Adverse Event Reporting Description Upon completion of this study, we retrospectively observed the occurrence of any adverse event in our patient population utilizing our electronic medical record. . Using the standardized clinical trials definition of "adverse event" we carefully determined the rate at which these events occurred.
    Arm/Group Title Control Group Theraworx Group CHG Group
    Arm/Group 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. 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. 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. 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.
    All Cause Mortality
    Control Group Theraworx Group CHG Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/59 (3.4%) 1/67 (1.5%) 1/77 (1.3%)
    Serious Adverse Events
    Control Group Theraworx Group CHG Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/59 (3.4%) 1/67 (1.5%) 1/77 (1.3%)
    Blood and lymphatic system disorders
    Pulmonary Embolism 0/59 (0%) 0 0/67 (0%) 0 1/77 (1.3%) 1
    Cardiac disorders
    Exacerbated Congestive Heart Failure 2/59 (3.4%) 2 0/67 (0%) 0 0/77 (0%) 0
    Vascular disorders
    Carotid Pseudo-aneurysm 0/59 (0%) 0 1/67 (1.5%) 1 0/77 (0%) 0
    Other (Not Including Serious) Adverse Events
    Control Group Theraworx Group CHG Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/59 (3.4%) 1/67 (1.5%) 3/77 (3.9%)
    Infections and infestations
    Surgical Site Infection 2/59 (3.4%) 2 1/67 (1.5%) 1 3/77 (3.9%) 3

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Ashish Shah
    Organization University of Alabama at Birmingham
    Phone 205-930-6722
    Email ashishshah@uabmc.edu
    Responsible Party:
    Ashish Shah, Assistant Professor, Department of Orthopaedics, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT03401749
    Other Study ID Numbers:
    • IRB-300000508
    First Posted:
    Jan 17, 2018
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022