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
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Drug: Chlorhexidine Gluconate 2% Wipe Other: Theraworx Bath Wipes||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
- Surgical Site infection [ Time Frame: Within 1 year of Surgery ]Clinical development of a surgical site infection
- Patient Compliance [ Time Frame: Day before and day of surgery ]Survey on patient's ability to follow recommendations
- Patient Satisfaction [ Time Frame: 1 year ]Survey of patient satisfaction
- Healthcare provider satisfaction [ Time Frame: 1 year ]Survey of nurse satisfaction
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
|Contact: Ashish B Shah, M.D.||email@example.com|
|Contact: Haley M McKissack, B.S.||firstname.lastname@example.org|
|United States, Alabama|
|UAB Highlands Hospital||Recruiting|
|Birmingham, Alabama, United States, 35205|
|Contact: Melanese M Leonard-Warren, RN, MSN, BSN 205-975-2671 email@example.com|