ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

deep neck infection

Condition category

Condition code

Infection

Other infectious diseases

Inflammatory and Immune System

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]

Not applicable

Comparator / control treatment

NA - This is an observational study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The patients who were diagnosed as deep neck infection, and the primary outcome was observation of their demographics (age and gender).

Timepoint [1]

At baseline

Primary outcome [2]

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]

At baseline

Primary outcome [3]

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]

At baseline

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

8/08/2012

Actual

8/08/2012

Date of last participant enrolment

Anticipated

31/12/2012

Actual

31/12/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

130

Accrual to date

Final

Recruitment outside Australia

Country [1]

China

State/province [1]

Guangdong

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Natural Science Foundation of China

Address [1]

Zhong shan 2nd Road 58,
Guangzhou 510080

Country [1]

China

Primary sponsor type

Individual

Name

Wenbin Lei

Address

Zhong shan 2nd Road 58,
Guangzhou 510080

Country

China

Secondary sponsor category [1]

Individual

Name [1]

Weiping Wen

Address [1]

Zhong shan 2nd Road 58,
Guangzhou 510080

Country [1]

China

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Institutional Review Board of the First Affiliated Hospital of Sun Yat-sen University

Ethics committee address [1]

Zhong shan 2nd Road 58,
Guangzhou 510080.

Ethics committee country [1]

China

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Prof Wenbin Lei

Address

Otorhinolaryngology Hospital, the First Affiliated Hospial, Sun Yat-Sen University,Zhong shan 2nd Road 58, Guangzhou 510080,

Country

China

Phone

+86-20-87333733

Fax

+86-20-87333733

leiwb2003@yahoo.com.cn

Contact person for public queries

Name

Weiqiang Yang

Address

Otorhinolaryngology Hospital, the First Affiliated Hospial, Sun Yat-Sen University,Zhong shan 2nd Road 58, Guangzhou 510080,

Country

China

Phone

+86-20-87333733

Fax

+86-20-87333733

ywqiang2011@yahoo.cn

Contact person for scientific queries

Name

Weiqiang Yang

Address

Otorhinolaryngology Hospital, the First Affiliated Hospial, Sun Yat-Sen University,Zhong shan 2nd Road 58, Guangzhou 510080

Country

China

Phone

+86-20-87333733

Fax

+86-20-87333733

ywqiang2011@yahoo.cn

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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