Unblinded randomized control trial on prophylactic antibiotic use in gustilo II open tibia fractures at Kenyatta National Hospital, Kenya

Citation:
Ondari JN, Masika MM, Ombachi RB, Ating’a JE. "Unblinded randomized control trial on prophylactic antibiotic use in gustilo II open tibia fractures at Kenyatta National Hospital, Kenya.". 2016.

Abstract:

Objective

To determine the difference in infection rate between 24 h versus five days of prophylactic antibiotic use in management of Gustilo II open tibia fractures.
Design

Unblinded randomized control trial.
Setting

Accident and Emergency, orthopedic wards and outpatient clinics at Kenyatta National Hospital (KNH).
Patients

The study involved patients aged 18–80 years admitted through accident and emergency department with Gustilo II traumatic open tibia fractures.
Intervention

Patients were randomized into either 24 hour or five day group and antibiotics started for 24 hours or five days after surgical debridement. The wounds were exposed and scored using ASEPSIS wound scoring system for infection after 48 h, 5 days and at 14 days.
Outcome measures

The main outcomes of interest were presence of infection at days 2, 5 and 14 and effect of duration to antibiotic administration on infection rate.
Results

There was no significant difference in infection rates between 24-hour and 5-day groups with infection rates of 23% (9/40) vs. 19% (7/37) respectively (p = 0.699). The infection rate was significantly associated with time lapsed before administration of antibiotics (p = 0.004).
Conclusion

In the use of prophylactic antibiotics for the management of Gustilo II traumatic open tibia fractures, there is no difference in infection rate between 24 hours and five days regimen but time to antibiotic administration correlates with infection rate. Antibiotic use for 24 hours only has proven adequate prophylaxis against infection. This is underlined in our study which we hope shall inform practice in our setting. A larger, more appropriately controlled study would be useful.

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