Infections

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Wounds and Injuries

Immune System Diseases

Eye Diseases

Skin Neoplasms

Communicable Diseases

Surgical Wound Infection

Hypersensitivity

Facies

Surgical Wound

Wound Infection

Eyelid Diseases

Disease Attributes

Postoperative Complications

Anti-Infective Agents

All Drugs and Chemicals

Gastrointestinal Agents

Pharmaceutical Solutions

Dermatologic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Erythromycin

Erythromycin Estolate

Erythromycin Ethylsuccinate

Erythromycin stearate

Lubricant Eye Drops

Petrolatum

Mineral Oil

Polymyxins

Bacitracin

Enzyme Inhibitors

Anti-Infective Agents, Local

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.

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.

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 Antibiotic Product

Mineral oil/petrolatum-based artificial tear ointment.

Topical Non-Antibiotic Ointment

Robert Kersten, MD

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.

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.

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.

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.

Topical Antibiotic Prophylaxis for Eyelids

The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery

The rate of superficial incisional or deep incisional surgical site infection (SSI) of clean and clean-contaminated wounds.

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.

A secondary outcome recording the rate of wound dehiscence after surgery.

A secondary outcome recording the rate of allergic contact dermatitis due to post-operative ointment.

University of California, San Francisco

Among participants who did not proceed with surgery or who had no post-operative follow-up, adverse event data for events specific to the post-operative period (i.e. allergic contact dermatitis or wound dehiscence) were not collected. These participants were excluded from the denominator in determining frequency of these adverse events.

The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week.

Topical Antibiotic Ointment

The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Smoking status

Participants were considered high risk for infection if they had a history of smoking or a medical history of a condition associated with immune suppression, such as diabetes mellitus, infection with human immunodeficiency virus, or autoimmune disease requiring immunosuppressive agents.

Spots Global Cancer Trial Database for surgical wound, recent