Trial Review

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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] 289572 0
nil
Universal Trial Number (UTN)
Trial acronym
SDDDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
abscess 299301 0
Condition category
Condition code
Infection 299297 299297 0 0
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] 295174 0
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] 298789 0
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] 298789 0
30 days post abscess drainage procedure
Secondary outcome [1] 325205 0
complication encountered according to the scale of Clavien-Dindo classification of surgical complications
Timepoint [1] 325205 0
30 days post abscess drainage procedure
Secondary outcome [2] 325235 0
length of stay - total length of stay in hospital. Data collected via hospital system (eRecord, ERIC)
Timepoint [2] 325235 0
will collect the LOS data at 30 days post abscess drainage procedure
Secondary outcome [3] 325236 0
theatre start time, Data collected via hospital system (ORMIS)
Timepoint [3] 325236 0
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?
No
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] 6043 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 13490 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 293946 0
Hospital
Name [1] 293946 0
Logan Hospital
Country [1] 293946 0
Australia
Primary sponsor type
Hospital
Name
Logan Hospital
Address
Armstrong Rd, Meadowbrook QLD 4131
Country
Australia
Secondary sponsor category [1] 292768 0
None
Name [1] 292768 0
Address [1] 292768 0
Country [1] 292768 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295369 0
Logan Ethics advisory group
Ethics committee address [1] 295369 0
Logan Hospital, Armstrong Rd, Meadowbrook QLD 4131
Ethics committee country [1] 295369 0
Australia
Date submitted for ethics approval [1] 295369 0
14/06/2016
Approval date [1] 295369 0
Ethics approval number [1] 295369 0

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 67030 0
Mr Yiu Ming Ho
Address 67030 0
Logan Hospital, Armstrong Rd, Meadowbrook QLD 4131
Country 67030 0
Australia
Phone 67030 0
+61732996300
Fax 67030 0
Email 67030 0
[email protected]
Contact person for public queries
Name 67031 0
Mr Yiu Ming Ho
Address 67031 0
Logan Hospital, Armstrong Rd, Meadowbrook QLD 4131
Country 67031 0
Australia
Phone 67031 0
+61732996300
Fax 67031 0
Email 67031 0
[email protected]
Contact person for scientific queries
Name 67032 0
Mr Yiu Ming Ho
Address 67032 0
Logan Hospital, Armstrong Rd, Meadowbrook QLD 4131
Country 67032 0
Australia
Phone 67032 0
+61732996300
Fax 67032 0
Email 67032 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

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