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Topical Antibiotic Prophylaxis for Eyelids

Primary Purpose

Antibiotic Side Effect, Eyelid; Wound, Eyelid Diseases

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Topical Antibiotic Product
Topical Non-Antibiotic Ointment
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibiotic Side Effect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Topical Antibiotic Ointment

Topical Non-Antibiotic Ointment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of High Risk Participants With Surgical Site Infections
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.
Number of Participants With Wound Dehiscence
A secondary outcome recording the rate of wound dehiscence after surgery.
Number of Participants With Allergic Contact Dermatitis
A secondary outcome recording the rate of allergic contact dermatitis due to post-operative ointment.

Full Information

First Posted
June 8, 2017
Last Updated
July 20, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03199911
Brief Title
Topical Antibiotic Prophylaxis for Eyelids
Official Title
The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
November 14, 2019 (Actual)
Study Completion Date
November 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic Side Effect, Eyelid; Wound, Eyelid Diseases, Surgical Wound Infection, Surgical Wound, Recent, Surgical Incision, Skin Cancer Face, Antibiotic Allergy, Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Allocation
Randomized
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical Antibiotic Ointment
Arm Type
Experimental
Arm Description
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.
Arm Title
Topical Non-Antibiotic Ointment
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Topical Antibiotic Product
Other Intervention Name(s)
Erythromycin, Bacitracin, Polysporin-Bacitracin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Topical Non-Antibiotic Ointment
Other Intervention Name(s)
Refresh PM
Intervention Description
Mineral oil/petrolatum-based artificial tear ointment.
Primary Outcome Measure Information:
Title
Number of Participants With Surgical Site Infections
Description
The rate of superficial incisional or deep incisional surgical site infection (SSI) of clean and clean-contaminated wounds.
Time Frame
First Post-Operative Visit (~7-14 days)
Secondary Outcome Measure Information:
Title
Number of High Risk Participants With Surgical Site Infections
Description
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.
Time Frame
First Post-Operative Visit (~7-14 days)
Title
Number of Participants With Wound Dehiscence
Description
A secondary outcome recording the rate of wound dehiscence after surgery.
Time Frame
First Post-Operative Visit (~7-14 days)
Title
Number of Participants With Allergic Contact Dermatitis
Description
A secondary outcome recording the rate of allergic contact dermatitis due to post-operative ointment.
Time Frame
First Post-Operative Visit (~7-14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kersten, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25905446
Citation
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.
Results Reference
background
PubMed Identifier
12867404
Citation
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.
Results Reference
background
PubMed Identifier
24646178
Citation
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.
Results Reference
background
PubMed Identifier
10219875
Citation
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.
Results Reference
background
PubMed Identifier
28222277
Citation
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.
Results Reference
background
PubMed Identifier
20800320
Citation
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.
Results Reference
background
PubMed Identifier
21821310
Citation
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.
Results Reference
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Topical Antibiotic Prophylaxis for Eyelids

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