None listed
Conditions
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.
Interventions
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 ortho
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.
Sponsors
Modilon General Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
10 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
We include all consecutive patients diagnosed clinically and radiologically as open long bone fracture of GA type II or III (A &B)
Exclusion criteria
Patients with evident infection or sub clinical infection and immunosuppressed
Outcome results
None listed