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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
27/05/2019
Date data sharing statement initially provided
27/05/2019
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.
Scientific title
A Randomised Control Trail to compare the infection rate in topical use of antibiotic vs conventional management of open fractures groups.
Secondary ID [1] 298076 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
open fracture 312581 0
Condition category
Condition code
Injuries and Accidents 311093 311093 0 0
Fractures

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 314307 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 319876 0
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.

Timepoint [1] 319876 0
6 months post fracture
Secondary outcome [1] 369756 0
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)
Timepoint [1] 369756 0
6 months post fracture
Secondary outcome [2] 369757 0
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.
Timepoint [2] 369757 0
6 months post fracture
Secondary outcome [3] 369758 0
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.
Timepoint [3] 369758 0
6 months post fracture

Eligibility
Key inclusion criteria
We include all consecutive patients diagnosed clinically and radiologically as open long bone fracture of GA type II or III
Minimum age
5 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with evident infection or sub clinical infection and immunosuppressed

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)
Allocation to group is placed in an opaque sealed envelope; we prepare 20 envelopes for each group, mix them and place in the box.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization is performed by manual drawing an opaque sealed envelope.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21438 0
Papua New Guinea
State/province [1] 21438 0
Madang

Funding & Sponsors
Funding source category [1] 302606 0
Hospital
Name [1] 302606 0
Modilon General Hospital
Address [1] 302606 0
Modilon General Hospital
PO Box 2119
Modilon Road
Madang
Papua New Guinea
Country [1] 302606 0
Papua New Guinea
Primary sponsor type
Hospital
Name
Modilon General Hospital
Address
Modilon General Hospital
PO Box 2119
Modilon Road
Madang
Papua New Guinea
Country
Papua New Guinea
Secondary sponsor category [1] 302519 0
University
Name [1] 302519 0
Divine Word University
Address [1] 302519 0
DWU (main campus)
PoBox 483
Madang
Papua New Guinea
Country [1] 302519 0
Papua New Guinea

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303241 0
Modilon Hospital Ethics Commitee (MHEC)
Ethics committee address [1] 303241 0
Modilon General Hospital
Po Box 2119
Modilon Rd.
Madang
Papua New Guinea
Ethics committee country [1] 303241 0
Papua New Guinea
Date submitted for ethics approval [1] 303241 0
Approval date [1] 303241 0
10/12/2018
Ethics approval number [1] 303241 0

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.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 92974 0
Dr Dickson Wak
Address 92974 0
Modilon General Hospital
Po Box 2119
Madang
Papua New Guinea
Country 92974 0
Papua New Guinea
Phone 92974 0
+67572863493
Fax 92974 0
Email 92974 0
dicksonrolfwak@gmail.com
Contact person for public queries
Name 92975 0
Prof Jerzy Kuzma
Address 92975 0
Divine Word University (main campus)
Po Box 483
Madang
Papua New Guinea
Country 92975 0
Papua New Guinea
Phone 92975 0
+67570057603
Fax 92975 0
+675 4222812
Email 92975 0
jkuzma@dwu.ac.pg
Contact person for scientific queries
Name 92976 0
Prof Jerzy Kuzma
Address 92976 0
Divine Word University (main campus)
Po Box 483
Madang
Papua New Guinea
Country 92976 0
Papua New Guinea
Phone 92976 0
+67570057603
Fax 92976 0
Email 92976 0
jkuzma@dwu.ac.pg

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD underlying main results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
public
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 1950 0
Study protocol
Citation [1] 1950 0
Link [1] 1950 0
Email [1] 1950 0
Other [1] 1950 0
Type [2] 1951 0
Informed consent form
Citation [2] 1951 0
Link [2] 1951 0
Email [2] 1951 0
Other [2] 1951 0
Summary results
No Results