Topical Antibiotic Prophylaxis for Eyelids

Surgical Site Infection Clinical Trial

Official title:

The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199911
• Other study ID #: 17-22309
• Status: Completed
• Phase: Phase 4
• Start date: October 2, 2017
• Est. completion date: November 14, 2019

Study information

• Verified date: July 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: November 14, 2019
• Est. primary completion date: November 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Allergy
• Antibiotic Side Effect
• Communicable Diseases
• Eyelid Diseases
• Eyelid; Wound
• Infection
• Skin Cancer Face
• Skin Neoplasms
• Surgical Incision
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Surgical Wound, Recent
• Wound Infection
• Wounds and Injuries

Intervention

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.
• Topical Non-Antibiotic Ointment
Mineral oil/petrolatum-based artificial tear ointment.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	First Post-Operative Visit (~7-14 days)
Secondary	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.	First Post-Operative Visit (~7-14 days)
Secondary	Number of Participants With Wound Dehiscence	A secondary outcome recording the rate of wound dehiscence after surgery.	First Post-Operative Visit (~7-14 days)
Secondary	Number of Participants With Allergic Contact Dermatitis	A secondary outcome recording the rate of allergic contact dermatitis due to post-operative ointment.	First Post-Operative Visit (~7-14 days)