Topical Antibiotic Prophylaxis for Eyelids

Study Overview
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Brief Summary
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The investigators propose a prospective randomized control trial testing the hypothesis that routine topical antibiotic prophylaxis does not significantly reduce the rate of infection after eyelid surgery.

Detailed Description
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The use of prophylactic topical antibiotic therapy after eyelid surgery is widespread. Due to increasing antibiotic resistance, antibiotic-related complications, and healthcare costs, the investigators wish to determine whether prophylactic post-operative antibiotic ointment is truly necessary. After all, existing dermatology literature currently recommends against the routine use of antibiotic ointment after various surgical procedures (e.g. Mohs surgery). The investigators aim to perform a prospective randomized control trial at the University of California, San Francisco. The investigators aim to recruit a total of 400 oculoplastics patients undergoing eyelid surgery or surgery involving peri-orbital incisions from 2017 through 2019.

Official Title
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The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery

Conditions
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Antibiotic Side Effect, Eyelid; Wound, Eyelid Diseases, Surgical Wound Infection, Surgical Wound, Recent, Surgical Incision, Skin Cancer Face, Antibiotic Allergy, Surgical Site Infection

Intervention / Treatment
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* Drug: Topical Antibiotic Product
* Drug: Topical Non-Antibiotic Ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 and older who are undergoing various eyelid procedures in an office, ambulatory care center, or operating room including but not limited to: blepharoplasty (upper and lower lids); ectropion repair; entropion repair; external dacryocystorhinostomy; external levator resection; eyelid lesion removal and/or biopsy; eyelid reconstruction and defect repair including after Mohs surgery; fat pad excision (upper and lower lids); gold or platinum weight implantation; internal levator resection; lateral tarsal strip; orbital fracture repair requiring periorbital incisions; orbitotomy requiring periorbital incisions; tarsorrhaphy; wedge excision. Patients undergoing repeat procedures will also be included. Exclusion Criteria: Patients aged younger than 18 years old who are undergoing the above eyelid procedures in an office, ambulatory care centers, operating rooms; patients undergoing chalazion removal; patients who have had previous wound infections at the site of the procedure; patients with oral or IV antibiotic use within 10 days prior to procedure; patients requiring IV antibiotics during the procedure; patients with grossly contaminated or inflamed wounds; patients with human or animal bites, patients with wounds resulting from trauma patients allergic to all study drug options.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical Antibiotic Ointment<br>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<br>* 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.<br>* Other names: Erythromycin, Bacitracin, Polysporin-Bacitracin;|
| Placebo Comparator: Topical Non-Antibiotic Ointment<br>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<br>* Mineral oil/petrolatum-based artificial tear ointment.<br>* Other names: Refresh PM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Surgical Site Infections | The rate of superficial incisional or deep incisional surgical site infection (SSI) of clean and clean-contaminated wounds. | First Post-Operative Visit ( 7-14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of High Risk Participants With Surgical Site Infections | 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. | First Post-Operative Visit ( 7-14 days) | 
| Number of Participants With Wound Dehiscence | A secondary outcome recording the rate of wound dehiscence after surgery. | First Post-Operative Visit ( 7-14 days) | 
| Number of Participants With Allergic Contact Dermatitis | A secondary outcome recording the rate of allergic contact dermatitis due to post-operative ointment. | First Post-Operative Visit ( 7-14 days) |