Phase 4
N=401
Topical Antibiotic Prophylaxis for Eyelids
Antibiotic Side Effect · Eyelid; Wound · Eyelid Diseases · Surgical Wound Infection · Surgical Wound, Recent
Bottom Line
View on ClinicalTrials.gov: NCT03199911 ↗Enrolled (actual)
401
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants With Surgical Site Infections — 0; 5 Participants — p=0.025
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Topical Antibiotic Product (Drug); Topical Non-Antibiotic Ointment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Surgical Site Infections |
0; 5 | 0.025 sig |
| SECONDARY Number of High Risk Participants With Surgical Site Infections |
0; 1 | — |
| SECONDARY Number of Participants With Wound Dehiscence |
7; 5 | 0.77 |
| SECONDARY Number of Participants With Allergic Contact Dermatitis |
1; 1 | 1.00 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03199911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.