Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03483363 |
Other study ID # |
HSC-DB-18-0038 |
Secondary ID |
|
Status |
Recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
October 9, 2018 |
Est. completion date |
March 2024 |
Study information
Verified date |
August 2022 |
Source |
The University of Texas Health Science Center, Houston |
Contact |
Donna M Martinez |
Phone |
(713) 500-5082 |
Email |
Donna.M.Martinez[@]uth.tmc.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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).
In April of 2020 a petition was made to add gentamycin and remove bacitracin after the FDA
warning of the toxic side effects of bacitracin and because the hospital where the study was
conducted has removed bacitracin from its formulary.
The modification was approved.
Description:
Protocol Title:
Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical
Wounds Principal
Investigators:
Co-Investigators:
Nagi Demian David Wainwright, Duc Lam, Georgian Brown Faculty Advisor: Nagi Demian, David
Wainwright 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 APPROVAL
DATE: 05/08/2020 UT Houston Protocol Template Page 2 of 4 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 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
APPROVAL DATE: 05/08/2020 UT Houston Protocol Template Page 3 of 4 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 APPROVAL
DATE: 05/08/2020 UT Houston Protocol Template Page 4 of 4 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.