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

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ClinicalTrials.gov Identifier: NCT03401749
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ashish Shah, University of Alabama at Birmingham

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
Surgical Site Infection Drug: Chlorhexidine Gluconate 2% Wipe Other: Theraworx Bath Wipes Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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 : November 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Surgical Site infection [ Time Frame: Within 1 year of Surgery ]
    Clinical development of a surgical site infection


Secondary Outcome Measures :
  1. Patient Compliance [ Time Frame: Day before and day of surgery ]
    Survey on patient's ability to follow recommendations

  2. Patient Satisfaction [ Time Frame: 1 year ]
    Survey of patient satisfaction

  3. Healthcare provider satisfaction [ Time Frame: 1 year ]
    Survey of nurse satisfaction



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401749


Contacts
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Contact: Ashish B Shah, M.D. 205-930-8339 ashishshah@uabmc.edu
Contact: Haley M McKissack, B.S. 904-982-6389 hmckissack@uabmc.edu

Locations
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United States, Alabama
UAB Highlands Hospital Recruiting
Birmingham, Alabama, United States, 35205
Contact: Melanese M Leonard-Warren, RN, MSN, BSN    205-975-2671    mnleonard@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: Ashish Shah, Assistant Professor, Department of Orthopaedics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03401749     History of Changes
Other Study ID Numbers: IRB-300000508
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Allantoin
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents