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Topical Antibiotic Prophylaxis for Eyelids

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ClinicalTrials.gov Identifier: NCT03199911
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Robert Kersten, 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.

Condition or disease Intervention/treatment Phase
Antibiotic Side Effect Eyelid; Wound Eyelid Diseases Surgical Wound Infection Surgical Wound, Recent Surgical Incision Skin Cancer Face Antibiotic Allergy Surgical Site Infection Drug: Topical Anti-Infective Product Drug: Topical Ointment Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: Randomization to one of two intervention arms (i.e. antibiotic ointment vs. placebo artificial tear ointment) will be performed prior to study recruitment by a qualified statistician. 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.
Primary Purpose: Prevention
Official Title: The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Topical Antibiotic Ointment
Intervention: 200 patients in the antibiotic arm will receive either erythromycin unless there is a specific contraindication (e.g. known allergy or lack of pharmacy availability). Those who are erythromycin allergic will receive bacitracin. If neither antibiotic is obtainable by the patient, polybacitracin will be prescribed instead. Antibiotic ointment is to be applied to the surgical incision(s) 4 times daily for 1 week.
Drug: Topical Anti-Infective Product
Topical antibiotic ointment will be erythromycin. If the patient has an erythromycin allergy, bacitracin will be prescribed. If the patient cannot obtain either (i.e. lack of availability at the pharmacy), polysporin-bacitracin will be prescribed. Allergy to all 3 study drugs means that a patient will be excluded from the study.
Other Name: Erythromycin, Bacitracin, Polysporin-Bacitracin

Placebo Comparator: Topical Artificial Tear Ointment
Intervention: 200 patients in the placebo group will receive artificial tear ointment to be applied to the surgical incision(s) 4 times daily for 1 week.
Drug: Topical Ointment
Artificial tear ointment
Other Name: Refresh PM




Primary Outcome Measures :
  1. Postoperative Infection Rate [ Time Frame: Postoperative visit week 1 ]
    The rate of superficial incisional and deep incisional surgical site infection (SSI) of clean and clean-contaminated wounds.


Secondary Outcome Measures :
  1. Postoperative Infection Rate in High-Risk Patients [ Time Frame: Postoperative visit week 1 ]
    The secondary outcome will be the rate of superficial and deep SSI in high infection-risk groups such as patients with diabetes, those who smoke, those on chronic high-dose steroids, etc.

  2. Complications [ Time Frame: Postoperative visit week 1 ]
    The classification of types of complications (e.g. allergic dermatitis) related to antibiotic ointment and artificial tear ointment use as well as their respective rates.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 dacrocystorhinostomy;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199911


Contacts
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Contact: Robert Kersten, MD (415) 353-2142 robert.kersten@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Robert Kersten, MD    415-353-2142    robert.kersten@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Robert Kersten, MD University of California, San Francisco

Publications:

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Responsible Party: Robert Kersten, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03199911     History of Changes
Other Study ID Numbers: 17-22309
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Skin Neoplasms
Eyelid Diseases
Surgical Wound
Wounds and Injuries
Neoplasms by Site
Neoplasms
Skin Diseases
Postoperative Complications
Pathologic Processes
Eye Diseases
Anti-Bacterial Agents
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Bacitracin
Antibiotics, Antitubercular
Anti-Infective Agents, Local
Lubricant Eye Drops
Anti-Infective Agents
Antitubercular Agents
Ophthalmic Solutions
Pharmaceutical Solutions
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors