Antibiotic Allergy, Antibiotic Side Effect, Eyelid Diseases, Eyelid; Wound, Skin Cancer Face, Surgical Incision, Surgical Site Infection, Surgical Wound Infection, Surgical Wound, Recent
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGTopical 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.
DRUGTopical Non-Antibiotic Ointment
Mineral oil/petrolatum-based artificial tear ointment.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Randomization to one of two intervention arms (i.e. antibiotic ointment vs. placebo artificial tear ointment) will be performed prior to study recruitment by REDCap software. Patients' randomization assignments will be revealed at the initial pre-operative visit or at time that procedure consent is obtained; the study team will not be aware of a subject's randomization assignment prior to that time.
Intervention model description
Patients will be randomized to one of two intervention arms (i.e. antibiotic ointment vs. placebo artificial tear ointment) and will not at any point cross over to the other arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Site Infections | First Post-Operative Visit (~7-14 days) | The rate of superficial incisional or deep incisional surgical site infection (SSI) of clean and clean-contaminated wounds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of High Risk Participants With Surgical Site Infections | First Post-Operative Visit (~7-14 days) | 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. |
| Number of Participants With Wound Dehiscence | First Post-Operative Visit (~7-14 days) | A secondary outcome recording the rate of wound dehiscence after surgery. |
| Number of Participants With Allergic Contact Dermatitis | First Post-Operative Visit (~7-14 days) | A secondary outcome recording the rate of allergic contact dermatitis due to post-operative ointment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topical Antibiotic Ointment The antibiotic arm received either erythromycin or a bacitracin containing ointment, depending on allergies, surgeon preference, and pharmacy availability. Patients were instructed to apply the ointment to the surgical incision(s) 4 times daily for 1 week. | 206 |
| Topical Non-Antibiotic Ointment The non-antibiotic ointment arm received mineral oil/petrolatum-based artificial tear ointment with instructions to apply it to the surgical incision(s) 4 times daily for 1 week. | 192 |
| Total | 398 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not proceed with surgery | 2 | 1 |
| Overall Study | Lost to Follow-up | 5 | 5 |
Baseline characteristics
| Characteristic | Total | Topical Antibiotic Ointment | Topical Non-Antibiotic Ointment |
|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 16 | 63.5 years STANDARD_DEVIATION 16.7 | 63.4 years STANDARD_DEVIATION 15.4 |
| Asplenia No | 397 Participants | 205 Participants | 192 Participants |
| Asplenia Yes | 1 Participants | 1 Participants | 0 Participants |
| Autoimmune disease No | 390 Participants | 200 Participants | 190 Participants |
| Autoimmune disease Yes | 8 Participants | 6 Participants | 2 Participants |
| Blepharoplasty No | 311 Participants | 158 Participants | 153 Participants |
| Blepharoplasty Yes | 87 Participants | 48 Participants | 39 Participants |
| Browplasty No | 395 Participants | 203 Participants | 192 Participants |
| Browplasty Yes | 3 Participants | 3 Participants | 0 Participants |
| Dacryocystorhinostomy No | 391 Participants | 205 Participants | 186 Participants |
| Dacryocystorhinostomy Yes | 7 Participants | 1 Participants | 6 Participants |
| Diabetes mellitus No | 343 Participants | 182 Participants | 161 Participants |
| Diabetes mellitus Yes | 55 Participants | 24 Participants | 31 Participants |
| Ectropion/Entropion repair No | 348 Participants | 181 Participants | 167 Participants |
| Ectropion/Entropion repair Yes | 50 Participants | 25 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 17 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 368 Participants | 189 Participants | 179 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Eyelid lesion removal and/or biopsy No | 326 Participants | 170 Participants | 156 Participants |
| Eyelid lesion removal and/or biopsy Yes | 72 Participants | 36 Participants | 36 Participants |
| High risk for infection No | 307 Participants | 162 Participants | 145 Participants |
| High risk for infection Yes | 91 Participants | 44 Participants | 47 Participants |
| Human immunodeficiency virus infection No | 394 Participants | 206 Participants | 188 Participants |
| Human immunodeficiency virus infection Yes | 4 Participants | 0 Participants | 4 Participants |
| Malignancy No | 396 Participants | 206 Participants | 190 Participants |
| Malignancy Yes | 2 Participants | 0 Participants | 2 Participants |
| Orbitotomy No | 379 Participants | 198 Participants | 181 Participants |
| Orbitotomy Yes | 19 Participants | 8 Participants | 11 Participants |
| Organ transplantation No | 397 Participants | 206 Participants | 191 Participants |
| Organ transplantation Yes | 1 Participants | 0 Participants | 1 Participants |
| Ptosis repair No | 314 Participants | 165 Participants | 149 Participants |
| Ptosis repair Yes | 84 Participants | 41 Participants | 43 Participants |
| Reconstruction after Mohs surgery No | 351 Participants | 181 Participants | 170 Participants |
| Reconstruction after Mohs surgery Yes | 47 Participants | 25 Participants | 22 Participants |
| Sex: Female, Male Female | 239 Participants | 127 Participants | 112 Participants |
| Sex: Female, Male Male | 159 Participants | 79 Participants | 80 Participants |
| Smoking status No | 366 Participants | 188 Participants | 178 Participants |
| Smoking status Unknown | 1 Participants | 0 Participants | 1 Participants |
| Smoking status Yes | 31 Participants | 18 Participants | 13 Participants |
| Tarsorrhaphy No | 394 Participants | 203 Participants | 191 Participants |
| Tarsorrhaphy Yes | 4 Participants | 3 Participants | 1 Participants |
| Wedge excision No | 368 Participants | 191 Participants | 177 Participants |
| Wedge excision Yes | 30 Participants | 15 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 208 | 0 / 193 |
| other Total, other adverse events | 8 / 208 | 6 / 193 |
| serious Total, serious adverse events | 0 / 208 | 0 / 193 |
Outcome results
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.
Time frame: First Post-Operative Visit (~7-14 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Topical Antibiotic Ointment | Number of Participants With Surgical Site Infections | 0 Participants |
| Topical Non-Antibiotic Ointment | Number of Participants With Surgical Site Infections | 5 Participants |
p-value: 0.025Fisher Exact
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.
Time frame: First Post-Operative Visit (~7-14 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Topical Antibiotic Ointment | Number of High Risk Participants With Surgical Site Infections | 0 Participants |
| Topical Non-Antibiotic Ointment | Number of High Risk Participants With Surgical Site Infections | 1 Participants |
Secondary
Number of Participants With Allergic Contact Dermatitis
A secondary outcome recording the rate of allergic contact dermatitis due to post-operative ointment.
Time frame: First Post-Operative Visit (~7-14 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Topical Antibiotic Ointment | Number of Participants With Allergic Contact Dermatitis | 1 Participants |
| Topical Non-Antibiotic Ointment | Number of Participants With Allergic Contact Dermatitis | 1 Participants |
p-value: 195% CI: [0.06, 14.77]Fisher Exact
Secondary
Number of Participants With Wound Dehiscence
A secondary outcome recording the rate of wound dehiscence after surgery.
Time frame: First Post-Operative Visit (~7-14 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Topical Antibiotic Ointment | Number of Participants With Wound Dehiscence | 7 Participants |
| Topical Non-Antibiotic Ointment | Number of Participants With Wound Dehiscence | 5 Participants |
p-value: 0.7795% CI: [0.42, 4.03]Fisher Exact