Phase 4
Completed N=401
Topical Antibiotic Prophylaxis for Eyelids
Antibiotic Side Effect · Eyelid; Wound · Eyelid Diseases · Surgical Wound Infection
Source: ClinicalTrials.gov NCT03199911 ↗
Enrolled (actual)
401
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants With Surgical Site Infections — 0; 5 Participants — p=0.025
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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. Informational only — not medical advice.