Topical Antibiotic Prophylaxis for Eyelids

NCT03199911 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 17-22309
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Surgical Site Infections

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

  First Post-Operative Visit (~7-14 days)

Secondary Outcomes (3)

• Number of High Risk Participants With Surgical Site Infections

  First Post-Operative Visit (~7-14 days)

• Number of Participants With Wound Dehiscence

  First Post-Operative Visit (~7-14 days)

• Number of Participants With Allergic Contact Dermatitis

  First Post-Operative Visit (~7-14 days)

Study Arms (2)

Topical Antibiotic Ointment

EXPERIMENTAL

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.

Drug: Topical Antibiotic Product

Topical Non-Antibiotic Ointment

PLACEBO COMPARATOR

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.

Drug: Topical Non-Antibiotic Ointment

Interventions

Topical Antibiotic Product 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.

Also known as: Erythromycin, Bacitracin, Polysporin-Bacitracin

Topical Antibiotic Ointment

Topical Non-Antibiotic Ointment DRUG

Mineral oil/petrolatum-based artificial tear ointment.

Also known as: Refresh PM

Topical Non-Antibiotic Ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (7)

• 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.

  PMID: 25905446 BACKGROUND

• 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.

  PMID: 12867404 BACKGROUND

• 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.

  PMID: 24646178 BACKGROUND

• 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.

  PMID: 10219875 BACKGROUND

• 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.

  PMID: 28222277 BACKGROUND

• 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.

  PMID: 20800320 BACKGROUND

• 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.

  PMID: 21821310 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Eyelid Diseases; Surgical Wound Infection; Surgical Wound

Interventions

Erythromycin; Bacitracin

Condition Hierarchy (Ancestors)

Eye Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Davin Ashraf MD
• Organization: University of California, San Francisco

davin.ashraf@ucsf.edu

415-353-2800

Study Officials

• Robert Kersten, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 27, 2017
• Study Start: October 2, 2017
• Primary Completion: November 14, 2019
• Study Completion: November 14, 2019
• Last Updated: July 21, 2020
• Results First Posted: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)