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An Observational Study Of The Correlation Between Intra-Abscess Pressures And The Severity Of Infection.

STUPP = The Pus Project - An Observational Study Of The Correlation Between Intra-Abscess Pressures And The Severity Of Infection.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12611000435987
Acronym
STUPP
Enrollment
20
Registered
2011-04-28
Start date
2011-06-16
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

An abscess is a localised collection of bacteria, dead tissue, and pus. There are no human studies demonstrating a link between increasing abscess pressures and the spread of infection. The current management is surgical incision and drainage of the abscess cavity. Once the abscess spreads it is associated with a prolonged stay in hospital and a longer recovery time. We propose to measure the abscess pressure in patients presenting to the Royal Darwin Hospital Emergency Department, and correlate the pressure with clinical indices of local and systemic inflammatory reaction.

Interventions

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

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.

Sponsors

Associate Professor Philip Carson
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes

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).

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026