Clinical trial NCT03483363
Conditions: Surgical Site Infection
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2018-10-09; Completion date: 2022-01-02
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS).

Previously, this study evaluated a different antibiotic, bacitracin, but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.

Detailed description:

Arms: arm 1: Fractures will be topically irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure.

\[previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.\] arm 2: Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic.
Interventions: intervention 1: topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline) intervention 2: topical irrigation with sterile normal saline (NS) intervention 3: intravenous (IV) prophylactic antibiotic
Intervention descriptions: intervention 1: Fractures will be irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. intervention 2: Fractures will be irrigated with sterile normal saline prior to closure. intervention 3: All arms with receive standard parenteral (IV) prophylactic antibiotic.

Protocol documents:
Prot_SAP_000.pdf: 
IRB NUMBER: HSC-DB-18-0038 
IRB APPROPVaAgLe D1 AofT4E: 05/08/2020
UT Houston Protocol Template 
Adapted from NIH protocol template and ICH Guidelines 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture 
Surgical Wounds 
 
NCT 03483363 
 
Version Date: 05/08/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


IRB NUMBER: HSC-DB-18-0038 
IRB APPROPVaAgLe D2 AofT4E: 05/08/2020
UT Houston Protocol Template 
Adapted from NIH protocol template and ICH Guidelines 
 
Protocol Title: 
Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture 
Surgical Wounds 
Principal 
Investigators: 
 
Co-Investigators: 
 
Nagi Demian 
 
David Wainwright, Justin Seaman, Duc Lam, Georgian Brown 
 
Faculty Advisor: 
Nagi Demian, David Wainwright, Justin Seaman 
 
Population: 
Adult Patients admitted to Memorial Hermann Hospital (MHH) for treatment 
of Midfacial fractures 
Number of Sites: 
Memorial Hermann Hospital 
 
Study Duration: 
Prospective trial, 4 years 
 
Subject Duration: 
Associated hospital stays, Follow up to eight weeks postoperatively 
 
 
 
General Information 
The purpose of this study is to evaluate the use of topical antibiotic irrigation (Gentamicin) and its ability 
to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS). 
 
Background Information 
The Centers for Disease Control and Prevention estimates that 16 million surgical procedures were 
performed in acute care hospitals in the United States in 2010 (CDC). A recent study found that surgical 
site infections (SSIs) accounted for roughly 31% of all hospital acquired infections (HAIs) (Magill). The 
overall infection rate for traumatic midfacial fracture is about 9% (Lauder). Current regimens applied for 
prevention of SSIs include: preoperative antiseptic preparation and systemic parenteral antibiotic 
prophylaxis, intraoperative aseptic techniques, and postoperative incision care (Mangram). 
Intraoperative topical antibiotic irrigation intraoperatively is becoming more prevalent, supplementing 
the recommended use of intravenous prophylactic administration of antibiotics prior to surgery 
(Andreasen). Typical irrigation agents include sterile saline, Gentamicin, chlorhexidine gluconate, 
betadine, Bacitracin, and hydrogen peroxide. The majority of prospective references reviewed were 
limited to orthopedic, abdominal, ocular, breast, dermatologic, and cardiothoracic surgeries with a 
significant lack of sources referencing maxillofacial surgeries (McHugh). The available reports on the use 
of topical antibiotic irrigation in prophylaxis of facial surgical wounds is insufficient. 
 
Objectives 
• 
Does the use of topical antibiotic irrigation (Gentamicin) reduce surgical site infections in 
midfacial fracture surgery compared to sterile NS? 
 
Study Design 
• 
Prospective randomized trial: All groups with receive standard parenteral (IV) prophylactic 
antibiotic. In the control group, the fractures will be irrigated with sterile normal saline prior to 
closure. In the trial group, the fractures will be irrigated with Gentamicin topical antibiotic 


IRB NUMBER: HSC-DB-18-0038 
IRB APPROPVaAgLe D3 AofT4E: 05/08/2020
UT Houston Protocol Template 
Adapted from NIH protocol template and ICH Guidelines 
 
(80mg diluted in 1L 0.9% NS) prior to closure. Patients will not receive postoperative oral 
antibiotics. 
• 
Double blinded: Intraoperative irrigation will be concealed (saline vs Gentamicin) to the patient 
and the surgeon. 
• 
Expected duration of study is about 4 years and subject participation is expected to be about 
200. 
• 
The primary outcome to be measured is the rate of surgical site infections. The main 
investigator (Dr. Demian) will determine SSI (evidence of infection: persistent swelling, fever, 
recurrent swelling, erythema, and purulent discharge). Statistical analysis plan will be 
multivariate: SSI, use of Gentamicin, type of fracture, past medical history, social history, days 
before surgery. 
• 
Assessment of efficacy. 
• 
Assessment of safety. 
 
Gentamicin information – Topical use 
• 
Please see separate package insert document for more detailed information 
• 
A topical irrigation solution may be compounded by dissolving appropriate amount of 
Gentamicin injection or Gentamicin compounding powder in 0.9% Sodium Chloride injection or 
sterile water for injection for a final concentration of 0.08mg/mL. 
• 
This drug is contraindicated in those individuals with a history of previous hypersensitivity or 
allergic reaction to it 
• 
Dosage form: 8mg/Vial, injection 
• 
Maximum doseage: 5 mg/kg/day IV/IM is FDA-approved maximum. There is no maximum dose 
stated for ophthalmic or topical administration. 
• 
There is no premixed solution. The Gentamicin is obtained at the hospital pharmacy and is 
mixed with 0.9% normal saline in the operating room by the scrub tech under sterile condition 
with nurse practitioner supervision (Georgian Brown) in order to maintain the blind. 80mg will 
be used per patient. 
 
Study Population 
• 
Inclusion: All patients 18 years of age and older who are planned for open reduction internal 
fixation of midfacial fractures as part of standard of care 
• 
Exclusion: Infected surgical sites, allergies to Gentamicin 
• 
Recruitment: Will recruit all patients who are admitted to Memorial Hermann hospital at Texas 
Medical Center 
 
Study Procedures 
• 
Expected number of visits will be about 5. First visit will be for evaluation in emergency 
department. Second visit will be for surgery. Also, patient will be monitored in the hospital 
postoperatively and will be seen for follow up in clinic. 
• 
Every case included will be randomized based on lottery system for intraoperative sterile saline 
vs Gentamicin irrigation 
• 
Every administered agent will not be known to patient or surgeon 
• 
Patient will be then followed and monitored as per standard of care (inpatient monitoring, clinic 
follow up after discharge, last follow up at 8 weeks) 
• 
The following will be considered evidence of infection: persistent swelling, fever, recurrent 
swelling, erythema, and purulent discharge 


IRB NUMBER: HSC-DB-18-0038 
IRB APPROPVaAgLe D4 AofT4E: 05/08/2020
UT Houston Protocol Template 
Adapted from NIH protocol template and ICH Guidelines 
 
• 
Patient information will be gathered to evaluate the type of surgery, medical history of patient, 
research intervention of irrigation, types of antibiotics used, inpatient recovery, and follow up 
care. The information will be recorded an encrypted separate electronic document to ensure 
protection of patient information: secureshare.uth.tmc.edu 
 
Data and Safety Monitoring 
• 
Adverse events are not expected 
• 
Data will be collected and kept by designated research assistants, Duc Lam and Georgie Brown. 
• 
Data will be kept on the secured website: secureshare.uth.tmc.edu 
• 
Interpretation of all information and results to be calculated at the conclusion of the last follow 
up of the last case included in the study to reduce bias 
• 
At the conclusion of the study, data kept will have no patient information but still will be stored 
in the secured location 
 
Statistics 
• 
The aim of this study is to mainly compare the statistical outcomes between each group. Once 
the data tabulation is completed, other statistical analysis may be pursued after consultation 
with the statistician in UT Health. 
• 
Prior to data requisition, UTHealth statisticians, Dr. Ruby Benjamin-Gardner and Dr. MinJae Lee, 
were consulted for sample size calculation assistance. 
• 
Given the prevalence of surgical wound infection in our target population is 9%, with a sample 
size of 100 per group (200 total), a type 1 error rate of 0.05 and a type 2 error rate of .80 (80% 
power), we will be able to detect a reduction of 9 percentage points, from 10% in the saline 
group to 1% in the topical antibiotic group. 
 
Ethics 
• 
IRB approval will be sought from CPHS. Start of project will be conducted only after all 
permissions and approval are granted. Chart reviews and data collection will be conducted only 
after all permissions and approval are granted 
• 
Consent will be obtained from each patient using standard consent forms for the specific 
surgery. A separate research consent form will be completed by each patient discussing the 
research study specifically. 
• 
Once IRB approval is granted, additional application to the respective hospital will be submitted 
individually to the respective research office and the offices of the respective chiefs of staff 
 
Data handling and record keeping 
• 
Data will be collected using medical record numbers avoiding any specific patient’s identifiers 
• 
Data will be secured in secureshare.uth.tmc.edu or similar UT Health approved storage media 
 
Quality control and assurance 
• 
Data collections will be performed by research assistants 
 
Publication Plan 
• 
Data and conclusion will be shared internally for quality improvement 
• 
Data will be also shared in local and national professional meetings 
• 
Future publications in professional journals 


IRB NUMBER: HSC-DB-18-0038 
IRB APPROPVaAgLe D5 AofT4E: 05/08/2020
UT Houston Protocol Template 
Adapted from NIH protocol template and ICH Guidelines 
 
Attachments 
• 
See specific data collection outline below 
 
Data Collection 
MRN 
Age 
Gender 
PMHx 
Medications 
Allergies 
Social history 
Injuries 
Type of fracture 
Days before Surgery 
Gentamicin 
No Gentamicin 
Post-op Hospital Course 
Follow up #1 
Follow up #2 
Infection 
No Infection 
Other Complications 
 
References 
1. Andreasen JO, Jensen SS, Schwartz O, Hillerup Y. A systematic review of prophylactic antibiotics 
in the surgical treatment of maxillofacial fractures. J Oral Maxillofac Surg. 2006 
Nov;64(11):1664-8. Review. PubMed PMID: 17052593. 
2. (CDC) “Surgical Site Infection (SSI) Event.” Centers for Disease Control, Jan. 2017, Web: 
https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf. 
3. Lauder A, Jalisi S, Spiegel J, Stram J, Devaiah A. Antibiotic prophylaxis in the management of 
complex midface and frontal sinus trauma. Laryngoscope. 2010 Oct;120(10):1940-5. doi: 
10.1002/lary.21081. PubMed PMID: 20824781. 
4. Magill SS, Hellinger W, Cohen J, Kay R, Bailey C, Boland B, Carey D, de Guzman J, Dominguez K, 
Edwards J, Goraczewski L, Horan T, Miller M, Phelps M, Saltford R, Seibert J, Smith B, Starling P, 
Viergutz B, Walsh K, Rathore M, Guzman N, Fridkin S. Prevalence of healthcare-associated 
infections in acute care hospitals in Jacksonville, Florida. Infect Control Hosp Epidemiol. 2012 
Mar;33(3):283-91. doi: 10.1086/664048. Epub 2012 Jan 12. PubMed PMID: 22314066; PubMed 
Central PMCID: PMC4648350. 
5. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical 
Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control 
Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; 
discussion 96. PubMed PMID: 10196487. 
6. McHugh SM, Collins CJ, Corrigan MA, Hill AD, Humphreys H. The role of topical antibiotics used 
as prophylaxis in surgical site infection prevention. J Antimicrob Chemother. 2011 
Apr;66(4):693-701. doi: 10.1093/jac/dkr009. Epub 2011 Feb 3. Review.