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Topical Antibiotic Prophylaxis for Eyelids

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ClinicalTrials.gov Identifier: NCT03199911
Recruitment Status : Completed
First Posted : June 27, 2017
Results First Posted : July 21, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
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 Antibiotic Product Drug: Topical Non-Antibiotic 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)
Actual Enrollment : 401 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 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.
Primary Purpose: Prevention
Official Title: The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery
Actual Study Start Date : October 2, 2017
Actual Primary Completion Date : November 14, 2019
Actual Study Completion Date : November 14, 2019

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 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 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.
Other Name: Erythromycin, Bacitracin, Polysporin-Bacitracin

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.
Drug: Topical Non-Antibiotic Ointment
Mineral oil/petrolatum-based artificial tear ointment.
Other Name: Refresh PM




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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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 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.

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


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Robert Kersten, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Study Protocol  [PDF] September 9, 2018
Statistical Analysis Plan  [PDF] April 1, 2020

Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03199911    
Other Study ID Numbers: 17-22309
First Posted: June 27, 2017    Key Record Dates
Results First Posted: July 21, 2020
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Wounds and Injuries
Surgical Wound
Postoperative Complications
Pathologic Processes
Neoplasms by Site
Neoplasms
Skin Diseases
Eye Diseases
Anti-Bacterial Agents
Erythromycin
Bacitracin
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local