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Trial registered on ANZCTR
Registration number
ACTRN12619000782134
Ethics application status
Approved
Date submitted
27/04/2019
Date registered
27/05/2019
Date last updated
8/05/2023
Date data sharing statement initially provided
27/05/2019
Date results information initially provided
8/05/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
A Randomised Control Trail to compare the infection rate of topical use of antibiotic vs conventional management of open fractures.
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Scientific title
A Randomised Control Trail to compare the infection rate in topical use of antibiotic vs conventional management of open fractures groups.
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Secondary ID [1]
298076
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
open fracture
312581
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Condition category
Condition code
Injuries and Accidents
311093
311093
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0
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Fractures
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Group 1: Apart from the conventional management of open fractures including early wound debridement and dressing, intravenously antibiotics (flucloxacillin adults >50kg typically 1g 6 hourly, children 100mg/kg in 4 doses + gentamycin 7mg/kg daily; continued for one week after the debridement) and fracture immobilization, intervention depends on topical application of 160mg Gentamycin to the wound just after the debridement. The antibiotic are administered by emergency nurse followed by the orthopedic ward nurse. The antibiotic administration details are recorded in the treatment sheet as well as in the research form.
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Intervention code [1]
314307
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Treatment: Drugs
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Comparator / control treatment
Group 2 (control): The conventional management of open fractures including early wound debridement and dressing, intravenous antibiotics ((flucloxacillin adults >50kg typically 1g 6 hourly, children 100mg/kg in 4 doses + gentamycin 7mg/kg daily; continued for one week after the debridement)) and fracture immobilization.
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Control group
Active
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Outcomes
Primary outcome [1]
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Infection rate including chronic osteomyelitis and septic non-union; it will be diagnosed based on clinical findings, laboratory tests, radiological findings (X-ray). Chronic osteomyelitis will be classified according to Cierny-Mader classification.
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Assessment method [1]
319876
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Timepoint [1]
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2 weeks and 6 weeks and 6 months post 1st procedure
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Secondary outcome [1]
369756
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time to bone union
Bony union will be assessed based on clinical findings (no pain and mobility at the fracture site) and X-ray (at least one cortex healed in both views)
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Assessment method [1]
369756
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Timepoint [1]
369756
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2 weeks and 6 weeks and 6 months post 1st procedure
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Secondary outcome [2]
369757
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length of hospital stay
Based on the research form records and assessed as total length of all hospital stays in connection with the recorded open fracture and expressed in days.
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Assessment method [2]
369757
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Timepoint [2]
369757
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6 months post fracture
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Secondary outcome [3]
369758
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number of operations
Based on the research form records, expressed as number of procedures performed in the operating theatre in connection with the recorded open fracture treatment until achieving bone union and/or eradication of infection.
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Assessment method [3]
369758
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Timepoint [3]
369758
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6 months post fracture
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Eligibility
Key inclusion criteria
We include all consecutive patients diagnosed clinically and radiologically as open long bone fracture of GA type II or III (A &B)
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Minimum age
10
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with evident infection or sub clinical infection and immunosuppressed
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to group is placed in an opaque sealed envelope; we prepare 20 envelopes for each group, mix them and place in the box.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization is performed by manual drawing an opaque sealed envelope.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Univariate analysis of categorical data will be performed using chi-square test and Fisher's exact test where appropriate, and continuous variables will be analysed using two-tailed Student t tests or Wilcoxon's rank sum test, as appropriate. Student t test will be done with equal or unequal variances based on analysis by the F test. Values are expressed as mean ± standard error (continuous variables) or percentage of the group of origin (categorical variables). All probability values are two-tailed. Odds ratio (OR) and 95% confidence intervals (CI) will be calculated. Statistical significance is defined as P < 0.05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
6/01/2019
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Date of last participant enrolment
Anticipated
30/12/2021
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Actual
30/12/2021
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Date of last data collection
Anticipated
30/06/2022
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Actual
30/06/2022
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Sample size
Target
120
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Accrual to date
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Final
120
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Recruitment outside Australia
Country [1]
21438
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Papua New Guinea
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State/province [1]
21438
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Madang
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Funding & Sponsors
Funding source category [1]
302606
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Hospital
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Name [1]
302606
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Madang General Hospital
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Address [1]
302606
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Madang General Hospital, PO Doc 2119, Modilon Road, Madang, Papua New Guinea
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Country [1]
302606
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Papua New Guinea
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Primary sponsor type
Hospital
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Name
Modilon General Hospital
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Address
Modilon General Hospital
PO Box 2119
Modilon Road
Madang
Papua New Guinea
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Country
Papua New Guinea
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Secondary sponsor category [1]
302519
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University
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Name [1]
302519
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Divine Word University
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Address [1]
302519
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DWU (main campus)
PoBox 483
Madang
Papua New Guinea
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Country [1]
302519
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Papua New Guinea
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303241
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Modilon Hospital Ethics Commitee (MHEC)
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Ethics committee address [1]
303241
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Modilon General Hospital
Po Box 2119
Modilon Rd.
Madang
Papua New Guinea
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Ethics committee country [1]
303241
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Papua New Guinea
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Date submitted for ethics approval [1]
303241
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Approval date [1]
303241
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10/12/2018
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Ethics approval number [1]
303241
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Summary
Brief summary
We randomly allocate consecutive patients with open fractures of long bones at Gustillo-Anderson grade 2 and 3 (A &B) into two group planning minimum 89 participants in each group.
Group 1 (intervention): besides conventional management of open fractures we apply topical gentamycin.
Group 2 (control) managed in a conventional way. We have no age or gender limits. Exclusion criteria are present infection or state of immunosupression. The primary outcome measue is infection rate, the secondary are: lenght of hospital stay, time to bone union, number of operations and comlication rate.
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Trial website
None
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Trial related presentations / publications
None
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Public notes
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Contacts
Principal investigator
Name
92974
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Dr Dickson Wak
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Address
92974
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Modilon General Hospital
Po Box 2119
Madang
Papua New Guinea
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Country
92974
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Papua New Guinea
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Phone
92974
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+67572863493
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Fax
92974
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Email
92974
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[email protected]
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Contact person for public queries
Name
92975
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Prof Jerzy Kuzma
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Address
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Divine Word University (main campus)
Po Box 483
Madang
Papua New Guinea
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Country
92975
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Papua New Guinea
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Phone
92975
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+67570057603
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Fax
92975
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+675 4222812
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Email
92975
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[email protected]
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Contact person for scientific queries
Name
92976
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Prof Jerzy Kuzma
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Address
92976
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Divine Word University (main campus)
Po Box 483
Madang
Papua New Guinea
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Country
92976
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Papua New Guinea
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Phone
92976
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+67570057603
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Fax
92976
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Email
92976
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD underlying main results only
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When will data be available (start and end dates)?
Immediately following publication, no end date
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Available to whom?
public
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Available for what types of analyses?
for IPD meta-analyses
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How or where can data be obtained?
access subject to approvals by Principal Investigator
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1950
Study protocol
Citation: Dickson Rollef Wak and Jerzy Kuzma. “A Randomised Control Trail to Compare Topical Use of Antibiotic Versus Conventional Management of Open Fractures”. EC Orthopaedics 14.5 (2023): 38-46
377479-(Uploaded-27-04-2019-12-37-13)-Study-related document.docx
1951
Informed consent form
377479-(Uploaded-27-04-2019-12-38-12)-Study-related document.docx
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Plain language summary
No
Results: We recorded a significant reduction of in...
[
More Details
]
Documents added automatically
No additional documents have been identified.
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