Topical Antibiotic Prophylaxis for Eyelids

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2019-11-14

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.

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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.

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Topical Antibiotic Product

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

Topical Non-Antibiotic Ointment

Intervention Type DRUG

Mineral oil/petrolatum-based artificial tear ointment.

Interventions

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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.

Intervention Type DRUG

Topical Non-Antibiotic Ointment

Mineral oil/petrolatum-based artificial tear ointment.

Intervention Type DRUG

Other Intervention Names

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Erythromycin, Bacitracin, Polysporin-Bacitracin Refresh PM

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes