Clinical trial · Interventional
Topical Antibiotic Prophylaxis for Eyelids
The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery
NCT03199911CI-TRIAL-00046066completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antibiotic Allergy | — | UNRESOLVED | — |
| Antibiotic Side Effect | — | UNRESOLVED | — |
| Eyelid Diseases | — | UNRESOLVED | — |
| Eyelid; Wound | — | UNRESOLVED | — |
| Skin Cancer Face | — | UNRESOLVED | — |
| Surgical Incision | — | UNRESOLVED | — |
| Surgical Site Infection | — | UNRESOLVED | — |
| Surgical Wound Infection | — | UNRESOLVED | — |
| Surgical Wound, Recent | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topical Antibiotic Product | Drug | — | UNRESOLVED |
| Topical Non-Antibiotic Ointment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Topical Antibiotic Ointment
- 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.
- interventionNames
- Drug: Topical Antibiotic Product
- type
- PLACEBO_COMPARATOR
- label
- Topical Non-Antibiotic Ointment
- 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.
- interventionNames
- Drug: Topical Non-Antibiotic Ointment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDFay 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. PMID 25905446
- BACKGROUNDCarter 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. PMID 12867404
- BACKGROUNDSaco 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. PMID 24646178
- BACKGROUNDMangram 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. PMID 10219875
- BACKGROUNDFerneini 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. PMID 28222277
- BACKGROUNDRogers 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. PMID 20800320
- BACKGROUNDLevender 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.