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CompletedPhase 1ACTRN12619000782134

A Randomised Control Trail to compare the infection rate of topical use of antibiotic vs conventional management of open fractures.

A Randomised Control Trail to compare the infection rate in topical use of antibiotic vs conventional management of open fractures groups.

Sponsor

Modilon General Hospital

Enrollment

120 participants

Start Date

Jan 6, 2019

Study Type

Interventional

Conditions

open fracture

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.

Eligibility

Sex: Both males and femalesMin Age: 10 YearssMax Age: 60 Yearss

Inclusion Criteria1

  • We include all consecutive patients diagnosed clinically and radiologically as open long bone fracture of GA type II or III (A &B)

Exclusion Criteria1

  • Patients with evident infection or sub clinical infection and immunosuppressed

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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

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.

Locations(1)

Madang, Papua New Guinea

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ACTRN12619000782134