Surgical Site Infection Clinical Trial
Official title:
The Role of Topical Antibiotic Prophylaxis in Eyelid Surgery
Verified date | July 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 401 |
Est. completion date | November 14, 2019 |
Est. primary completion date | November 14, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 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. | 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. | 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. | First Post-Operative Visit (~7-14 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04096885 -
The Inselspital Surgical Cohort Study
|
||
Terminated |
NCT03820648 -
Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy
|
N/A | |
Completed |
NCT04067843 -
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study
|
N/A | |
Terminated |
NCT04042077 -
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
|
Phase 3 | |
Completed |
NCT05841576 -
Anaesthetic Management Guided by COMET Measurements
|
N/A | |
Withdrawn |
NCT05338281 -
NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT
|
N/A | |
Recruiting |
NCT03042091 -
Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery
|
Early Phase 1 | |
Completed |
NCT01697748 -
Prospective Study on Cesarean Wound Outcomes
|
N/A | |
Terminated |
NCT01789697 -
Text Message Study
|
N/A | |
Recruiting |
NCT05966961 -
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
|
||
Recruiting |
NCT05077592 -
Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections
|
Phase 4 | |
Recruiting |
NCT05502380 -
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
|
Phase 3 | |
Recruiting |
NCT05763602 -
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
|
Phase 4 | |
Recruiting |
NCT03221023 -
Intrawound Vancomycin Prophylaxis for Neural Stimulator
|
Phase 2/Phase 3 | |
Completed |
NCT03257202 -
Topical Treatment and Prevalence of P. Acnes
|
Phase 2 | |
Completed |
NCT06154720 -
Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
|
||
Not yet recruiting |
NCT06465901 -
A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI
|
N/A | |
Not yet recruiting |
NCT04820075 -
Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery
|
N/A | |
Recruiting |
NCT03561376 -
Zinc Oxide Versus Petrolatum Following Skin Surgery
|
Early Phase 1 | |
Not yet recruiting |
NCT04496180 -
Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy
|
N/A |