Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000435987
Ethics application status
Approved
Date submitted
19/04/2011
Date registered
28/04/2011
Date last updated
18/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
An Observational Study Of The Correlation Between Intra-Abscess Pressures And The Severity Of Infection.
Scientific title
STUPP = The Pus Project - An Observational Study Of The Correlation Between Intra-Abscess Pressures And The Severity Of Infection.
Secondary ID [1] 260041 0
Nil
Universal Trial Number (UTN)
U1111-1120-8706
Trial acronym
STUPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Isolated and uniloculated subcutaneous abscesses 265703 0
Condition category
Condition code
Surgery 265842 265842 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Description of condition
The condition is an isolated and uniloculated subcutaneous abscess.

Research aims and questions
The project is designed to:
1. Establish the feasibility of measuring the pressure of abscesses
2. To explore the possible correlation between intra-abscess pressure and clinical signs of the severity of local and systemic infection
3. This will add new scientific knowledge to abscess formation
4. This may lead to the useful clinical investigation to determine the timing of surgical intervention in the future

The project will use a descriptive questionnaire to record abscess pressures; abscess volumes; and, clinical, systemic and microbiological manifestations of the abscess.

Setting
The entire project will be conducted at the Royal Darwin Hospital (RDH), at the Division of Surgery. The pressure measurements will be taken in theatre when the patients are under general anaesthesia.

Procedure
This project will be an observational study. Initially there will be a pilot study of the first 20 cases to statistically validate the outcomes and make adjustments to the methods, or other aspects of the study if required.

To determine the best method of intra-abscess pressure measurement half (10 cases) will have their abscess pressure measured with the intra-compartmental pressure monitoring system and half (10 cases) with the intra-arterial (arterial line) system. This will establish the most accurate device for the measurement of intra-abscess pressure.

The project will use a descriptive perioperative questionnaire to be completed prior to and post abscess drainage by the operating surgeon. RDH surgeons will be informed of the project and questionnaire protocol as well as encouraged to complete the necessary documentation. The investigators will follow up completed questionnaires daily and complete additional documentation.

All patients will be provided with an information sheet about the project. Informed consent will be obtained from patients aged 16 years or above with the legal capacity to consent to confirm their participation in the project. The information sheet and consent form outline the procedure used to measure the abscess pressure and requests access to patient records for the purposes of the project. This will be explained comprehensively to the patient. The Northern Territory Interpreter Service will be utilised for Aboriginal and/or Torres Strait Islander persons as well as persons of other countries. The procedure for measuring abscess pressure will not affect patient management. Hence, the RDH consent for procedures/treatment form will be completed for incision and drainage of the abscess.

The patient observation time will be for the duration of hospital admission.
Intervention code [1] 264461 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266600 0
Outcome 1: To establish the feasibility of measuring the pressure of abscesses
Measurement:
Intra-compartmental pressure monitoring system
Intra-arterial (arterial line) system
Timepoint [1] 266600 0
Upon surgical drainage of the abscess in the operating theatre at Royal Darwin Hospital
Secondary outcome [1] 276083 0
Outcome 2: The correlation between intra-abscess pressure and clinical signs of the severity of local and systemic infection
Measurement:
Extent of skin necrosis and presence of necrotising fasciitis
Pulse rate - pulse oximeter
Mean arterial pressure - blood pressure cuff
Temperature - thermometer
C-reactive protein - biochemistry
White cell count - biochemistry
Blood cultures - microbiology
Timepoint [1] 276083 0
On admission to the Royal Darwin Hospital

Eligibility
Key inclusion criteria
All patients with an isolated and uniloculated subcutaneous abscess presenting to the Royal Darwin Hospital, Emergency Department who are aged 16 years or above with the legal capacity to consent. The abscess must require surgical drainage in the operating theatre. Patients must be otherwise healthy (see exclusion criteria).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All patients with:
- A multiloculated abscess,
- Other potential sources of infection, for example pneumonia,
- Increased mortality risk, and
- Major immune compromise, for example chronic renal failure, heart failure, or diabetes.
Patients who are pregnant as well as children (aged less than 16 years) or those without the legal capacity to consent will also be excluded from the project.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264932 0
Self funded/Unfunded
Name [1] 264932 0
Lovelace Osei-Tutu
Country [1] 264932 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Philip Carson
Address
P.O. Box 41326,
Casuarina, Northern Territory, 0811
Country
Australia
Secondary sponsor category [1] 264030 0
Hospital
Name [1] 264030 0
Royal Darwin Hospital
Address [1] 264030 0
Rocklands Drive,
Casuarina, Northern Territory, 0810
Country [1] 264030 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266890 0
NT Department of Health and Menzies School of Health Research
Ethics committee address [1] 266890 0
Ethics committee country [1] 266890 0
Australia
Date submitted for ethics approval [1] 266890 0
30/03/2011
Approval date [1] 266890 0
29/04/2011
Ethics approval number [1] 266890 0
2011-1570

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32521 0
Address 32521 0
Country 32521 0
Phone 32521 0
Fax 32521 0
Email 32521 0
Contact person for public queries
Name 15768 0
Dr Lovelace Osei-Tutu
Address 15768 0
4/10-14 Omeo Street,
Brinkin, Northern Territory, 0810
Country 15768 0
Australia
Phone 15768 0
+61 8 8922 8888
Fax 15768 0
+61 8 8922 8286
Email 15768 0
[email protected]
Contact person for scientific queries
Name 6696 0
Associate Professor Philip Carson
Address 6696 0
P.O. Box 41326,
Casuarina, Northern Territory, 0811
Country 6696 0
Australia
Phone 6696 0
+61 8 8922 8249
Fax 6696 0
+61 8 8922 8601
Email 6696 0
[email protected]

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.