ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000890437p

Ethics application status

Submitted, not yet approved

Date submitted

29/06/2016

Date registered

6/07/2016

Date last updated

6/07/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

A trial on same day discharge after drainage of abscesses

Scientific title

A Randomised Clinical Trial on Same Day Discharge post Drainage of Abscess

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

SDDDA

Linked study record

Health condition

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

abscess

Condition category

Condition code

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention arm: Same day discharge following Drainage of Abscess

*Pre-operative: Same as the standardised discharge patients. In addition, the Acute Care at Home service will be notified for discharge planning. The Duty Anaesthetist and theatre coordinator will be notified that the patient will be for same day discharge. The procedure will be scheduled with priority for same day discharge.
*Intra-operative: Same as the standardised discharge patients.
*Post-operative: The patient will be discharged home from recovery, with an admission to the Acute Care at Home service. The admission will be completed on the next day and community wound care will be arranged during the admission.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Intervention: Same day discharge
Control: admit overnight as in-patient (current standard of care)

Control group

Active

Outcomes

Primary outcome [1]

Outcome: re-admission

Re-admission is defined by
*Patient return to hospital emergency to receive further care related to the abscess or the drainage procedure.

This outcome is assessed by the patient returned to hospital, in which the team responsible to the trial will be contacted since it is the treating team. Patients will also be phoned at 30 days post-discharge to assess whether they have presented to other hospitals.

Timepoint [1]

30 days post abscess drainage procedure

Secondary outcome [1]

complication encountered according to the scale of Clavien-Dindo classification of surgical complications

Timepoint [1]

30 days post abscess drainage procedure

Secondary outcome [2]

length of stay - total length of stay in hospital. Data collected via hospital system (eRecord, ERIC)

Timepoint [2]

will collect the LOS data at 30 days post abscess drainage procedure

Secondary outcome [3]

theatre start time, Data collected via hospital system (ORMIS)

Timepoint [3]

will collect the LOS data at 30 days post abscess drainage procedure

Eligibility

Key inclusion criteria

Adult population with an abscess (perianal, pilonidal and/or cutaneous) and presented to Logan Hospital emergency

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients will be excluded if they:

Were determined by the treating surgeon that they have systemic inflammatory response and not suitable for early discharge.

Have other reasons that patients need to remain as in-patients, determined during the admission process.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

treatment team will be notify during request for admission. the patient will be allocated to an arm (early discharge or standard discharge) and therefore the allocation process is blinded to the treatment team.

The allocation process:
allocation involved contacting the holder of the allocation schedule who is the in-charge surgeon not in the emergency department. Central computerised randomisation will be performed by the surgeon and notify the admission staff (registrar).

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

centralised computer generated randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

non-inferior study.
intervention (n=50) and control group (n=50) with 5% drop out

If there is truly no difference between the standard and experimental treatment, then 96 patients are required to be 90% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference in favour of the standard group of more than 6%

alpha 5%
1-beta 90%
percentage of complication in intervention group 1%
percentage of complication in control group 1%
sample size 45 in each group
sample size 50 in each group if 5% drop out

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

11/07/2016

Actual

Date of last participant enrolment

Anticipated

31/10/2016

Actual

Date of last data collection

Anticipated

5/12/2016

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Logan Hospital - Meadowbrook

Recruitment postcode(s) [1]

4131 - Meadowbrook

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Logan Hospital

Address [1]

Armstrong Rd, Meadowbrook QLD 4131

Country [1]

Australia

Primary sponsor type

Hospital

Name

Logan Hospital

Address

Armstrong Rd, Meadowbrook QLD 4131

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Logan Ethics advisory group

Ethics committee address [1]

Logan Hospital, Armstrong Rd, Meadowbrook QLD 4131

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/06/2016

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Post-operative care usually includes an overnight hospital stay, to ensure adequate analgesia, satisfactory haemostasis. Patients with an abscess drained will stay until the next morning with examination of the wound and the removal of the haemostatic pack.
It is the fact that there is a logistic reason to keep the patients postoperatively. Baker et al illustrated their similar experience in NZ about theatre access (Baker 2009). Drainage of an abscess received a relatively low priority since it can be done by more junior staff after hours. Patients tend to have prolonged stays if access to theatre is an issue. There is currently no evidence to keep post abscess drainage patient in the hospital otherwise (Akkapulu 2014). It is time to encourage a better use of hospital resources in managing this common condition. The proposed change is to perform the drainage procedure early at the start of the ASU theatre list with minimal anaesthesia. There is evidence that for lower torso procedures, a smaller dose of spinal anaesthesia enables early ambulatory and shorter recovery period from anaesthesia. The patient is then referred to Acute Care at Home service for observation and to be discharged on the next day. Adequate analgesia and antibiotics will be dispensed prior the patient is being discharge from recovery. The ASU team can be contacted if concerns are raised by the Acute Care at Home service. The patient is then referred to Community Wound services for post-operative wound care.
The complication and re-admission rate post drainage are very low (<1%) in the current management of abscesses, according to the ASU internal audit. It is important to ensure this low complication and re-admission rate continue in the new management model. The purpose of this trial is to demonstrate the safety of this new management.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Yiu Ming Ho

Address

Logan Hospital, Armstrong Rd, Meadowbrook QLD 4131

Country

Australia

Phone

+61732996300

Fax

YiuMing.Ho@health.qld.gov.au

Contact person for public queries

Name

Yiu Ming Ho

Address

Logan Hospital, Armstrong Rd, Meadowbrook QLD 4131

Country

Australia

Phone

+61732996300

Fax

YiuMing.Ho@health.qld.gov.au

Contact person for scientific queries

Name

Yiu Ming Ho

Address

Logan Hospital, Armstrong Rd, Meadowbrook QLD 4131

Country

Australia

Phone

+61732996300

Fax

YiuMing.Ho@health.qld.gov.au

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.

Trial Review

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