Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients
NCT ID: NCT03401749
Last Updated: 2022-05-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
203 participants
INTERVENTIONAL
2018-11-01
2020-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control Group
Usual preadmission surgery instructions (shower the night before).
No interventions assigned to this group
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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled and deemed healthy enough to undergo orthopaedic surgery
* Willing and able to comply with protocol
Exclusion Criteria
* Contraindication to CHG or Theraworx
* Previous allergic reaction to CHG or Theraworx
* Surgeon's Discretion
18 Years
64 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Ashish Shah
Assistant Professor, Department of Orthopaedics
Principal Investigators
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ashish shah, md
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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UAB Highlands Hospital
Birmingham, Alabama, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB-300000508
Identifier Type: -
Identifier Source: org_study_id
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