Topical Antibiotic Prophylaxis for Eyelids

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

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

Treatments: Drug: Topical Non-Antibiotic Ointment; Drug: Topical Antibiotic Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03199911

17-22309

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 401 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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401 participants in 2 patient groups, including a placebo group

Topical Antibiotic Ointment

Experimental group

Description:

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.

Treatment:

Drug: Topical Antibiotic Product

Topical Non-Antibiotic Ointment

Placebo Comparator group

Description:

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.

Treatment:

Drug: Topical Non-Antibiotic Ointment