Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001253796
Ethics application status
Approved
Date submitted
17/10/2013
Date registered
14/11/2013
Date last updated
17/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating if antibiotics given before complex skin surgery on the ear,nose or below knee will prevent infection
Scientific title
Do antibiotics given before complex skin surgery on the ear,nose or below knee prevent infection: a prospective randomized placebo-controlled double blinded trial.
Secondary ID [1] 283378 0
nil
Universal Trial Number (UTN)
U1111-1148-9139
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection 290269 0
Condition category
Condition code
Surgery 290658 290658 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2g (in 4 capsules) cephalexin given orally 30-60 minutes prior to flap or graft surgery on the ear, nose or below knee
Intervention code [1] 288094 0
Treatment: Drugs
Comparator / control treatment
Placebo (4 capsules containing microcrystalline cellulose and calcium carbonate- these look identical to those containing cephalexin)
Control group
Placebo

Outcomes
Primary outcome [1] 290673 0
Infection within 30 days of surgery.
Research nurse will call participant 1 month following surgery to check if they were prescribed antibiotics for infection at surgical site of interest.
Antibiotics will be given if there is:
a) Purulent discharge from the incisional wound
b) Pain, heat or localised swelling
c) Erythema > 1 cm from wound edges
A confirming swab will also be taken if infection is suspected
Timepoint [1] 290673 0
30 days
Secondary outcome [1] 305035 0
nil
Timepoint [1] 305035 0
nil

Eligibility
Key inclusion criteria
flap or graft surgery to nose, ear or below knee
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infection at time of surgery; allergy to penicillin or cephalosporins; antibiotic use within 48hrs of surgery; wider excision if previously recruited to trial; allergy to sutures or dressings used in trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment- identical looking capsules containing either placebo or antibiotic are placed into sealed numbered containers off-site (at compounding pharmacy). Allocation sequence will not be revealed to clinic staff or participants until cessation of trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Currently infection rates for flap & graft surgery on the ear in nose is 20%. It was assumed that with the intervention infection rates would drop to 4%.
To show this with statistical confidence (power in excess of 80%; significance level 0.05) 59 patients are required in each group. Allowing for 20% drop-out 142 in total will need to be recruited to each group (71 intervention & 71 placebo).
For the below knee surgery component of the trial we anticipated a 25% infection rates for flap and graft closures below knee. Our hypothesis was that antibiotic prophylaxis would reduce infection rate to 5%. Forty-four patients were required in each study group to show this with statistical confidence (power in excess of 80%; significance level 0.05). We planned to recruit a minimum of 110 participants (55 intervention and 55 placebo) allowing for a 25% drop out
Data analysis will be by intention to treat. Bivariate statistical tests will be used to test whether the randomisation process was successful. If so, chi-square tests will be used to see if infection was less in the intervention group. If not multivariate logistic regression analysis will be used to assess the impact of the intervention on infection rates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/10/2013
Actual
4/12/2013
Date of last participant enrolment
Anticipated
31/10/2014
Actual
28/02/2016
Date of last data collection
Anticipated
Actual
25/03/2016
Sample size
Target
252
Accrual to date
Final
252
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7468 0
4812 - Gulliver

Funding & Sponsors
Funding source category [1] 288137 0
Other
Name [1] 288137 0
Skin Repair Skin cancer Clinic
Country [1] 288137 0
Australia
Funding source category [2] 297777 0
Other Collaborative groups
Name [2] 297777 0
Skin Cancer college of Australasia
Country [2] 297777 0
Australia
Primary sponsor type
Other
Name
Skin Repair Skin Cancer Clinic
Address
66 Mooney St
Gulliver
Queensland 4812
Country
Australia
Secondary sponsor category [1] 286854 0
None
Name [1] 286854 0
Address [1] 286854 0
Country [1] 286854 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290050 0
Townsville Hospital and Health Services HREC
Ethics committee address [1] 290050 0
Ethics committee country [1] 290050 0
Australia
Date submitted for ethics approval [1] 290050 0
Approval date [1] 290050 0
20/09/2013
Ethics approval number [1] 290050 0
13/QTHS/61

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

Contacts
Principal investigator
Name 43518 0
Dr Helena Rosengren
Address 43518 0
James Cook University
School of Medicine
Townsville, QLD 4811
Country 43518 0
Australia
Phone 43518 0
+61 7 4779 0099
Fax 43518 0
+61 7 4779 0098
Email 43518 0
[email protected]
Contact person for public queries
Name 43519 0
Helena Rosengren
Address 43519 0
James Cook University
School of Medicine
Townsville, QLD 4811
Country 43519 0
Australia
Phone 43519 0
+61 7 4779 0099
Fax 43519 0
+61 7 4779 0098
Email 43519 0
[email protected]
Contact person for scientific queries
Name 43520 0
Helena Rosengren
Address 43520 0
James Cook University
School of Medicine
Townsville, QLD 4811
Country 43520 0
Australia
Phone 43520 0
+61 7 4779 0099
Fax 43520 0
+61 7 4779 0098
Email 43520 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
SourceTitleYear of PublicationDOI
Dimensions AIEffect of a single prophylactic preoperative oral antibiotic dose on surgical site infection following complex dermatological procedures on the nose and ear: a prospective, randomised, controlled, double-blinded trial2018https://doi.org/10.1136/bmjopen-2017-020213
N.B. These documents automatically identified may not have been verified by the study sponsor.