Topical Antibiotic Prophylaxis for Eyelids

Overview

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 Title of Study: “The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 14, 2019

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.

Interventions

  • Drug: 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.
  • Drug: Topical Non-Antibiotic Ointment
    • Mineral oil/petrolatum-based artificial tear ointment.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Surgical Site Infections
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert Kersten, MD, Principal Investigator, University of California, San Francisco

References

Fay A, Nallasamy N, Bernardini F, Wladis EJ, Durand ML, Devoto MH, Meyer D, Hartstein M, Honavar S, Osaki MH, Osaki TH, Santiago YM, Sales-Sanz M, Vadala G, Verity D. Multinational Comparison of Prophylactic Antibiotic Use for Eyelid Surgery. JAMA Ophthalmol. 2015 Jul;133(7):778-84. doi: 10.1001/jamaophthalmol.2015.0789.

Carter SR, Stewart JM, Khan J, Archer KF, Holds JB, Seiff SR, Dailey RA. Infection after blepharoplasty with and without carbon dioxide laser resurfacing. Ophthalmology. 2003 Jul;110(7):1430-2. doi: 10.1016/S0161-6420(03)00447-0.

Saco M, Howe N, Nathoo R, Cherpelis B. Topical antibiotic prophylaxis for prevention of surgical wound infections from dermatologic procedures: a systematic review and meta-analysis. J Dermatolog Treat. 2015 Apr;26(2):151-8. doi: 10.3109/09546634.2014.906547. Epub 2014 Apr 8.

Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.

Ferneini EM, Halepas S, Aronin SI. Antibiotic Prophylaxis in Blepharoplasty: Review of the Current Literature. J Oral Maxillofac Surg. 2017 Jul;75(7):1477-1481. doi: 10.1016/j.joms.2017.01.025. Epub 2017 Feb 1.

Rogers HD, Desciak EB, Marcus RP, Wang S, MacKay-Wiggan J, Eliezri YD. Prospective study of wound infections in Mohs micrographic surgery using clean surgical technique in the absence of prophylactic antibiotics. J Am Acad Dermatol. 2010 Nov;63(5):842-51. doi: 10.1016/j.jaad.2010.07.029. Epub 2010 Aug 30.

Levender MM, Davis SA, Kwatra SG, Williford PM, Feldman SR. Use of topical antibiotics as prophylaxis in clean dermatologic procedures. J Am Acad Dermatol. 2012 Mar;66(3):445-51. doi: 10.1016/j.jaad.2011.02.005. Epub 2011 Aug 6.

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