Topical Antibiotic Prophylaxis for Eyelids
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|ClinicalTrials.gov Identifier: NCT03199911|
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : August 19, 2019
|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 Anti-Infective Product Drug: Topical Ointment||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 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 a qualified statistician. 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|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Topical Antibiotic Ointment
Intervention: 200 patients in the antibiotic arm will receive either erythromycin unless there is a specific contraindication (e.g. known allergy or lack of pharmacy availability). Those who are erythromycin allergic will receive bacitracin. If neither antibiotic is obtainable by the patient, polybacitracin will be prescribed instead. Antibiotic ointment is to be applied to the surgical incision(s) 4 times daily for 1 week.
Drug: Topical Anti-Infective Product
Topical antibiotic ointment will be erythromycin. If the patient has an erythromycin allergy, bacitracin will be prescribed. If the patient cannot obtain either (i.e. lack of availability at the pharmacy), polysporin-bacitracin 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 Artificial Tear Ointment
Intervention: 200 patients in the placebo group will receive artificial tear ointment to be applied to the surgical incision(s) 4 times daily for 1 week.
Drug: Topical Ointment
Artificial tear ointment
Other Name: Refresh PM
- Postoperative Infection Rate [ Time Frame: Postoperative visit week 1 ]The rate of superficial incisional and deep incisional surgical site infection (SSI) of clean and clean-contaminated wounds.
- Postoperative Infection Rate in High-Risk Patients [ Time Frame: Postoperative visit week 1 ]The secondary outcome will be the rate of superficial and deep SSI in high infection-risk groups such as patients with diabetes, those who smoke, those on chronic high-dose steroids, etc.
- Complications [ Time Frame: Postoperative visit week 1 ]The classification of types of complications (e.g. allergic dermatitis) related to antibiotic ointment and artificial tear ointment use as well as their respective rates.
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
|Contact: Robert Kersten, MD||(415) firstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Robert Kersten, MD 415-353-2142 email@example.com|
|Principal Investigator:||Robert Kersten, MD||University of California, San Francisco|