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The role of topical antibiotic prophylaxis in eyelid surgery: interim analysis of a pilot randomized controlled trial.

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Posterboard#: B0221

Abstract Number: 6241 - B0221

AuthorBlock: Qinyun Wang1, Oluwatobi O. Idowu1, Sombat Tanaboonyawat2,1, Thomas S. Copperman1, M. Reza Vagefi1, Robert C. Kersten1
1UCSF Ophthalmology, San Francisco, California, United States; 2Department of Ophthalmology, Phramongkutklao College of Medicine, Royal Thai Army, , Thailand;

DisclosureBlock: Qinyun Wang, None; Oluwatobi O. Idowu, None; Sombat Tanaboonyawat, None; Thomas S. Copperman, None; M. Reza Vagefi, None; Robert C. Kersten, None;

Purpose
With rising antibiotic resistance and healthcare costs, it has been advocated that topical antibiotic prophylaxis be withheld in routine eyelid surgery, which has low surgical site infection (SSI) rates. As such, we performed a pilot randomized control trial (Clinical Trial Registration Identifier: NCT03199911) to determine the feasibility of evaluating surgical site infection incidence after eyelid surgery both with and without the use of topical antibiotic prophylaxis.

Methods
With Institutional Review Board (IRB) approval, we conducted a randomized controlled trial in which adults (i.e. subjects aged 18 and older) undergoing eyelid procedures received either topical antibiotic (i.e. erythromycin) or placebo (i.e. lubricating) ointment for 1 week after surgery. The primary outcome was occurrence of superficial and deep incisional SSI at postoperative visit week 1; SSI was defined per CDC surgical site infection criteria, modified for the eyelid area. Secondary outcome included adverse events such as contact dermatitis. The collected data was de-identified for interim analysis, which was carried out using the Fischer Exact test.

Results
At interim analysis, 264 eligible subjects were enrolled and randomized, while 252 subjects (126 in the topical antibiotic arm and 126 in the placebo arm) with complete data were analyzed. The overall mean age of subjects was 63.14 years, with a 61% female predominance. In the antibiotic group, there was a 0% SSI incidence and 0.8% contact dermatitis incidence. In the placebo group, there was a 3.18% SSI incidence and 0.8% dermatitis incidence. The difference in infection incidence between the two arms was not statistically significant (p-value = 0.122).

Conclusions
Although SSI incidence was higher in subjects who did not receive prophylactic antibiotics, findings from this interim analysis suggest that there is no clear role for topical antibiotic prophylaxis in routine eyelid surgery. A future, more robustly-powered study would be required to substantiate our findings.

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