Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Antibiotic Ointment | Experimental | 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. |
|
| Topical Non-Antibiotic Ointment | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Antibiotic Product | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | First Post-Operative Visit (~7-14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | First Post-Operative Visit (~7-14 days) |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Kersten, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25905446 | Background | Fay 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. | |
| 12867404 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2018 | May 17, 2020 |
Not provided
Not provided
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.
Not provided
Not provided
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.
Not provided
|
|
| Topical Non-Antibiotic Ointment | Drug | Mineral oil/petrolatum-based artificial tear ointment. |
|
|
| Number of Participants With Wound Dehiscence | A secondary outcome recording the rate of wound dehiscence after surgery. | First Post-Operative Visit (~7-14 days) |
| Number of Participants With Allergic Contact Dermatitis | A secondary outcome recording the rate of allergic contact dermatitis due to post-operative ointment. | First Post-Operative Visit (~7-14 days) |
| Carter 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. |
| 24646178 | Background | Saco 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. |
| 10219875 | Background | Mangram 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. |
| 28222277 | Background | Ferneini 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. |
| 20800320 | Background | Rogers 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. |
| 21821310 | Background | Levender 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. |
| 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. |
| Did Not Proceed With Surgery |
|
| Received Allocated Treatment |
|
| Lost to Follow-up |
|
| Primary Outcome Analyzed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Data not available for 3 participants who did not proceed with surgery.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Smoking status | Count of Participants | Participants |
| ||||||||||||||||
| High risk for infection | Participants were considered high risk for infection if they had a history of smoking or a medical history of a condition associated with immune suppression, such as diabetes mellitus, infection with human immunodeficiency virus, or autoimmune disease requiring immunosuppressive agents. | Count of Participants | Participants |
| |||||||||||||||
| Asplenia | Count of Participants | Participants |
| ||||||||||||||||
| Autoimmune disease | Count of Participants | Participants |
| ||||||||||||||||
| Diabetes mellitus | Count of Participants | Participants |
| ||||||||||||||||
| Human immunodeficiency virus infection | Count of Participants | Participants |
| ||||||||||||||||
| Malignancy | Count of Participants | Participants |
| ||||||||||||||||
| Organ transplantation | Count of Participants | Participants |
| ||||||||||||||||
| Blepharoplasty | Count of Participants | Participants |
| ||||||||||||||||
| Browplasty | Count of Participants | Participants |
| ||||||||||||||||
| Dacryocystorhinostomy | Count of Participants | Participants |
| ||||||||||||||||
| Ectropion/Entropion repair | Count of Participants | Participants |
| ||||||||||||||||
| Eyelid lesion removal and/or biopsy | Count of Participants | Participants |
| ||||||||||||||||
| Ptosis repair | Count of Participants | Participants |
| ||||||||||||||||
| Reconstruction after Mohs surgery | Count of Participants | Participants |
| ||||||||||||||||
| Orbitotomy | Count of Participants | Participants |
| ||||||||||||||||
| Tarsorrhaphy | Count of Participants | Participants |
| ||||||||||||||||
| Wedge excision | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | First Post-Operative Visit (~7-14 days) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | First Post-Operative Visit (~7-14 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Wound Dehiscence | A secondary outcome recording the rate of wound dehiscence after surgery. | Posted | Count of Participants | Participants | First Post-Operative Visit (~7-14 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Allergic Contact Dermatitis | A secondary outcome recording the rate of allergic contact dermatitis due to post-operative ointment. | Posted | Count of Participants | Participants | First Post-Operative Visit (~7-14 days) |
|
|
Adverse events were collected until the final post-operative visit (approximately 3 months).
Among participants who did not proceed with surgery or who had no post-operative follow-up, adverse event data for events specific to the post-operative period (i.e. allergic contact dermatitis or wound dehiscence) were not collected. These participants were excluded from the denominator in determining frequency of these adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 208 | 0 | 208 | 8 | 208 |
| EG001 | 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. | 0 | 193 | 0 | 193 | 6 | 193 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic contact dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Allergic contact dermatitis at the surgical site. |
| |
| Wound dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment | Dehiscence of the surgical wound. |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Davin Ashraf MD | University of California, San Francisco | 415-353-2800 | davin.ashraf@ucsf.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2020 | May 19, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005141 | Eyelid Diseases |
| D013530 | Surgical Wound Infection |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D001414 | Bacitracin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| No |
|
| Unknown |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
|
|
|
|
|