A randomized controlled trial assessing the effectiveness of additional local gentamicin injection on reduction of infection rates in patients with open tibial fracture

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

TCTR

Registry ID

TCTR20170625002

Enrollment

142

Registered

2017-06-25

Start date

2017-10-26

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

open tibial fracture open tibial fracture

Interventions

normal saline injection into the wound of open tibial fracture,local gentamicin injection into the wound of open tibial fracture

Placebo Comparator Drug,Experimental Drug

normal saline,local gentamic injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with open tibial fracture type II and type IIIA, according to Gustilo-Anderson classification.

Exclusion criteria

Exclusion criteria: -Patients who have preexisting infection at the operative site. -Patients who are known to have major systemic infection at the time of injury. -Patients who have pathologic open fracture. -Patients who have a history of gentamicin allergy or a contraindication to gentamicin use, or eGFR<60 ml/min/1.73 m^2. -Patients who have moderate or severe head injury. (Glasgow coma score less than 13). -Patients who are uncooperative.

Design outcomes

Primary

Measure	Time frame
Infection and nonunion rates 6 years percents of Infection and nonunion rates	—

Secondary

Measure	Time frame
gentamicin concentration from the wound 6 years mcg/ml	—

Countries

Thailand

Contacts

Public Contactsatapong pisuitthanakan

Hatyai hospital

satapong11@hotmail.com66-91-8466227

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026