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Table 3 Inclusion and exclusion criteria

From: A study protocol for a Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia) in Dar es Salaam, Tanzania

Inclusion criteria

Exclusion criteria

1. Age ≥ 18 years

1. Time from injury to presentation > 48 h

2. Open tibial shaft fracture meeting the following criteria:

2. Time from injury to surgery > 7 days

 a. OTA type 42

3. Aminoglycoside allergy

 b. Primarily closable wound

4. GA IIIB or IIIC open fractures

 c. GA I, II, or IIIA

5. Bilateral open tibia fractures

 

6. Severe brain (GCS < 12) or spinal cord injury

 

7. Severe vascular injury

 

8. Severe burns (> 10% TBSA or > 5% TBSA with full thickness or circumferential injury)

 

9. Pathologic fracture

 

10. History of ipsilateral active limb infection

 

11. Unlikely to complete follow-up

  1. Abbreviations: OTA Orthopaedic Trauma Association, GA Gustilo-Anderson, GCS Glasgow Coma Scale, TBSA total body surface area