The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000482763
Ethics application status
Approved
Date submitted
21/04/2013
Date registered
30/04/2013
Date last updated
30/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Deep neck infection in China
Scientific title
The demographics, etiology, bacteriology, disease comorbidity, imaging, treatment, complications and prognosis of deep neck infection in China.
Secondary ID [1] 282221 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
deep neck infection 288956 0
Condition category
Condition code
Infection 289289 289289 0 0
Other infectious diseases
Inflammatory and Immune System 289290 289290 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Deep neck infection is defined as infection in the potential spaces and fascial planes of the neck. Although the incidence of deep neck infection has decreased significantly with the wide use of antibiotics, this condition is still common and present a constant challenge as it may lead to lethal complications such as descending mediastinitis, airway obstruction, jugular vein thrombosis, pericarditis, pleural empyema and arterial erosion. The diagnosis was confirmed by clinical symptoms, imaging studies, needle aspiration, and surgery. 130 patients diagnosed as deep neck infection in our hospital were observed,and their demographics, etiology, bacteriology, disease comorbidity, imaging, treatment, complications and prognosis were analysed. The patients were observed since they got hospitalization till they were discharged from hospital after recovery or died.
Intervention code [1] 287006 0
Not applicable
Comparator / control treatment
NA - This is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289400 0
The patients who were diagnosed as deep neck infection, and the primary outcome was observation of their demographics (age and gender).
Timepoint [1] 289400 0
At baseline
Primary outcome [2] 289412 0
The patients who were diagnosed as deep neck infection, and the primary outcome was to find out if the deep neck infection patients had systemic diseases. The outcome was assessed by checking the medical records.
Timepoint [2] 289412 0
At baseline
Primary outcome [3] 289413 0
The patients who were diagnosed as deep neck infection, and the primary outcome was observation of their complications. We reviewed the patients' medical records to confirm if the patients have complications such as descending mediastinitis, airway obstruction, jugular vein thrombosis, pericarditis, pleural empyema and arterial erosion.
Timepoint [3] 289413 0
At baseline
Secondary outcome [1] 302452 0
The patients who were diagnosed as deep neck infection, and the secondary outcome was observation of their hospitalization time. We reviewed the patients' medical records to count the hospitalization time of the patients.
Timepoint [1] 302452 0
At baseline

Eligibility
Key inclusion criteria
The diagnosis of patient's deep neck infection was confirmed by clinical manifestation, imaging studies, needle aspiration, or surgery.
Minimum age
1 Days
Maximum age
82 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cases of superficial infections, limited intraoral abscesses, peritonsillar abscesses, cervical necrotizing fasciitis, and infections secondary to penetrating or surgical neck trauma were excluded.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
t-test and chi-square test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5038 0
China
State/province [1] 5038 0
Guangdong

Funding & Sponsors
Funding source category [1] 287144 0
Government body
Name [1] 287144 0
National Natural Science Foundation of China
Address [1] 287144 0
Zhong shan 2nd Road 58,
Guangzhou 510080
Country [1] 287144 0
China
Primary sponsor type
Individual
Name
Wenbin Lei
Address
Zhong shan 2nd Road 58,
Guangzhou 510080
Country
China
Secondary sponsor category [1] 285912 0
Individual
Name [1] 285912 0
Weiping Wen
Address [1] 285912 0
Zhong shan 2nd Road 58,
Guangzhou 510080
Country [1] 285912 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289143 0
Institutional Review Board of the First Affiliated Hospital of Sun Yat-sen University
Ethics committee address [1] 289143 0
Zhong shan 2nd Road 58,
Guangzhou 510080.
Ethics committee country [1] 289143 0
China
Date submitted for ethics approval [1] 289143 0
Approval date [1] 289143 0
Ethics approval number [1] 289143 0

Summary
Brief summary
Background: The study aims to summarize our experience of deep neck infection and compare with cases ever reported as well as to estimate incidence trends in China.
Methods: Patients diagnosed as deep neck infection in the Division of Otolaryngology in the first Affiliated Hospital of Sun Yat-sen University from 2001 to 2011 were screened retrospectively for demographics, etiology, bacteriology, disease comorbidity, imaging, treatment, complications, duration of hospitalization, and outcomes.
Results: A total number of 130 patients were enrolled (60.8% male, 39.2% female). Average age was 32.9 +/-
22.8 years. 47 (36.2%) were under 20 years old. 45 were children (< 18 years of age). 27 patients (20.8%) had associated disease, 63.0% (17/27) of them had diabetes mellitus (DM). The parapharyngeal space (29.6%) was the most common involved space and 26.2% of patients had two or more involved spaces. Pharyngeal infections and odontogenic infections were the top two most common causes of deep neck infection (36.2% and 27.6% of the known causes, respectively). The etiology remained unknown in 72 patients (55.4%). Streptococcus viridians (49.0%) was the most common pathogen in this study. 86 (66.2%) patients underwent surgical drainage. 9 of 31 patients (23.8%) who had complications received either tracheotomy or intubation. 1 (mortality rate, 0.8%) died of sepsis and multiple organ dysfunction syndrome (MODS).
Conclusion: High level of drug-resistance makes deep neck infection unusual and complicated because it may make children predisposed for deep neck infection in China. Cervicothoracic contrast-enhanced CT scans are necessary for deep neck infection patients caused by cervical foreign body because they are easier to get descending mediastinitis. Needle aspiration and high dose intravenous antibiotics are sufficient in selected cases with good response to antibiotics, small abscess and no lethal complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38874 0
Prof Wenbin Lei
Address 38874 0
Otorhinolaryngology Hospital, the First Affiliated Hospial, Sun Yat-Sen University,Zhong shan 2nd Road 58, Guangzhou 510080,
Country 38874 0
China
Phone 38874 0
+86-20-87333733
Fax 38874 0
+86-20-87333733
Email 38874 0
leiwb2003@yahoo.com.cn
Contact person for public queries
Name 38875 0
Dr Weiqiang Yang
Address 38875 0
Otorhinolaryngology Hospital, the First Affiliated Hospial, Sun Yat-Sen University,Zhong shan 2nd Road 58, Guangzhou 510080,
Country 38875 0
China
Phone 38875 0
+86-20-87333733
Fax 38875 0
+86-20-87333733
Email 38875 0
ywqiang2011@yahoo.cn
Contact person for scientific queries
Name 38876 0
Dr Weiqiang Yang
Address 38876 0
Otorhinolaryngology Hospital, the First Affiliated Hospial, Sun Yat-Sen University,Zhong shan 2nd Road 58, Guangzhou 510080
Country 38876 0
China
Phone 38876 0
+86-20-87333733
Fax 38876 0
+86-20-87333733
Email 38876 0
ywqiang2011@yahoo.cn

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary