Topical Antibiotic Prophylaxis for Eyelids

Phase 4

Completed

• Conditions: Surgical Wound Infection; Surgical Incision; Surgical Site Infection; Antibiotic Side Effect; Eyelid Diseases; Surgical Wound, Recent; Skin Cancer Face; Eyelid; Wound; Antibiotic Allergy
• Interventions: Drug: Topical Antibiotic Product; Drug: Topical Non-Antibiotic Ointment

• Registration Number: NCT03199911
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-24
• Study First Posted: 2017-06-27
• Study Start: 2017-10-02
• Primary Completion: 2019-11-14
• Study Completion: 2019-11-14
• Results First Submitted: 2020-05-19
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-20
• Last Update Submitted: 2020-07-20
• Results First Posted: 2020-07-21
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Antibiotic Ointment	Topical Antibiotic Product	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.
Topical Non-Antibiotic Ointment	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States