Antibiotics prophylaxis for open tibial fractureS

Effective duration of antibiotic prophylaxis in controlling infection in open tibial fractures - A randomised control Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/026083

Enrollment

240

Registered

2020-06-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S898- Other specified injuries of lowerleg

Interventions

Intervention1: A- 2 DAYS: Inj CEFUROXIME 1.5 g Intravenous loading dose followed by Inj CEFUROXIME 750mg Intravenous Q8H to cover gram positive bacterias For 2 days Inj AMIKACIN 1g Intravenous OD to

Eligibility

Inclusion criteria

Inclusion criteria: All isolated extra articular open type 3a and type 3 b open fractures of both bone leg Age more than 18 years upto 70 years

Exclusion criteria

Exclusion criteria: Immunocompromised patients Injury debridement interval more than 24 hours Poly trauma patients Debridement done elsewhere open fracture with vascular injury chronic kindney failure/liver failure patient

Design outcomes

Primary

Measure	Time frame
Compare the Incidence of infection( based on CDC criteria) in two groups receiving different duration of prophylactic antibioticsTimepoint: 1.Before discharge 2.One month 3.Three months	—

Secondary

Measure	Time frame
to compare ifection rate of open fracture in differant age and sexTimepoint: 1.Before discharge 2.One month 3.Three months	—

Countries

India

Contacts

Public ContactDr Mahshook irfan P C

Ganga medical centre Hospital pvt ltd

pcmirfan@gmail.com09037419261

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026