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Completed

NCT Number: NCT03199911

Topical Antibiotic Prophylaxis for Eyelids

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.

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Key information

Conditions

Antibiotic Side Effect Antibiotic Allergy Eye Diseases Eyelid Diseases Eyelid; Wound Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Skin Cancer Face Surgical Incision Surgical Site Infection Surgical Wound Surgical Wound Infection Surgical Wound, Recent Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Erythromycin, Bacitracin, Polysporin-Bacitracin

Topical Non-Antibiotic Ointment

Drug

Mineral oil/petrolatum-based artificial tear ointment.

Other names: Refresh PM

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2017
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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