Topical Antibiotic Prophylaxis for Eyelids
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|ClinicalTrials.gov Identifier: NCT03199911|
Recruitment Status : Completed
First Posted : June 27, 2017
Results First Posted : July 21, 2020
Last Update Posted : July 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Antibiotic Side Effect Eyelid; Wound Eyelid Diseases Surgical Wound Infection Surgical Wound, Recent Surgical Incision Skin Cancer Face Antibiotic Allergy Surgical Site Infection||Drug: Topical Antibiotic Product Drug: Topical Non-Antibiotic Ointment||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||401 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized to one of two intervention arms (i.e. antibiotic ointment vs. placebo artificial tear ointment) and will not at any point cross over to the other arm.|
|Masking:||None (Open Label)|
|Masking Description:||Randomization to one of two intervention arms (i.e. antibiotic ointment vs. placebo artificial tear ointment) will be performed prior to study recruitment by REDCap software. Patients' randomization assignments will be revealed at the initial pre-operative visit or at time that procedure consent is obtained; the study team will not be aware of a subject's randomization assignment prior to that time.|
|Official Title:||The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery|
|Actual Study Start Date :||October 2, 2017|
|Actual Primary Completion Date :||November 14, 2019|
|Actual Study Completion Date :||November 14, 2019|
Experimental: Topical Antibiotic Ointment
Intervention: 200 patients in the antibiotic arm will receive either erythromycin or bacitracin, based on allergies, surgeon preference, and antibiotic availability. If neither antibiotic is obtainable by the patient, bacitracin polymyxin will be prescribed instead. Antibiotic ointment is to be applied to the surgical incision(s) 4 times daily for 1 week.
Drug: Topical Antibiotic Product
Topical antibiotic ointment will be erythromycin or bacitracin. If the patient cannot obtain either (e.g. lack of availability at the pharmacy), bacitracin polymyxin will be prescribed. Allergy to all 3 study drugs means that a patient will be excluded from the study.
Other Name: Erythromycin, Bacitracin, Polysporin-Bacitracin
Placebo Comparator: Topical Non-Antibiotic Ointment
Intervention: 200 patients in the placebo group will receive mineral oil/petrolatum-based artificial tear ointment to be applied to the surgical incision(s) 4 times daily for 1 week.
Drug: Topical Non-Antibiotic Ointment
Mineral oil/petrolatum-based artificial tear ointment.
Other Name: Refresh PM
- Number of Participants With Surgical Site Infections [ Time Frame: First Post-Operative Visit (~7-14 days) ]The rate of superficial incisional or deep incisional surgical site infection (SSI) of clean and clean-contaminated wounds.
- Number of High Risk Participants With Surgical Site Infections [ Time Frame: First Post-Operative Visit (~7-14 days) ]A secondary outcome is the rate of superficial or deep SSI in participants considered high risk for infection due to comorbidities such as smoking, exogenous immunosuppressive agent use, or medical conditions causing immunosuppression such as diabetes mellitus.
- Number of Participants With Wound Dehiscence [ Time Frame: First Post-Operative Visit (~7-14 days) ]A secondary outcome recording the rate of wound dehiscence after surgery.
- Number of Participants With Allergic Contact Dermatitis [ Time Frame: First Post-Operative Visit (~7-14 days) ]A secondary outcome recording the rate of allergic contact dermatitis due to post-operative ointment.
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): NCT03199911
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Robert Kersten, MD||University of California, San Francisco|