Clinical trial NCT03199911: Topical Antibiotic Prophylaxis for Eyelids
Official title: The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antibiotic Side Effect
Eyelid; Wound
Eyelid Diseases
Surgical Wound Infection
Surgical Wound, Recent
Surgical Incision
Skin Cancer Face
Antibiotic Allergy
Surgical Site Infection
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of Participants With Surgical Site Infections
timeFrame: First Post-Operative Visit (~7-14 days)
Secondary outcomes:
measure: Number of High Risk Participants With Surgical Site Infections
timeFrame: First Post-Operative Visit (~7-14 days)
measure: Number of Participants With Wound Dehiscence
timeFrame: First Post-Operative Visit (~7-14 days)
measure: Number of Participants With Allergic Contact Dermatitis
timeFrame: First Post-Operative Visit (~7-14 days)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Robert Kersten, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.