Topical Antibiotic Prophylaxis for Eyelids

July 20, 2020 updated by: University of California, San Francisco

The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

401

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Refresh PM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First Post-Operative Visit (~7-14 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First Post-Operative Visit (~7-14 days)
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.
First Post-Operative Visit (~7-14 days)
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.
First Post-Operative Visit (~7-14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Robert Kersten, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2017

Primary Completion (Actual)

November 14, 2019

Study Completion (Actual)

November 14, 2019

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 24, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-22309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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