Effectiveness of hyperbaric oxygen therapy in the treatment of the open tibial fractures. Open clinical trial, randomized, prospective and controlled.

• Conditions: Open tibial fractures; MedDRA version: 14.1Level: LLTClassification code 10030647Term: Open fracture of unspecified part of tibiaSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2011-003697-93-ES
• Lead Sponsor: Hospital Universitario de Canarias

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

? Subjects of both sexes between 18 and 55.
? Open fracture grade II or III of warm Gustilo classification (Table 1).
? Less than 24 hours of the accident.
? Signing the informed consent of study.
Is not permitted the inclusion of the same patient more than once
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Contraindications to oxygen therapy (page 8)
? unstable polytrauma.
? chronic peripheral arterial ischemia in the limb after effect.
? Pregnancy (beta HCG determination of blood to all female patients)
? Neoplastic disease.
? Previous fracture of the tibia affects.
? Past infection affects the tibia.
? Refusal of the patient to participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified