Health Condition 1: null- open tibial fracture with severe soft tissue injuries.
Conditions
Interventions
Intervention1: Hyperbaric oxygen therapy: 12 HBO sessions over 8days at 2.4 ATA pressure for 90 minutes of oxygen therapy.And treatment is twice daily for the first 3 days.Patients followed up for 2 y
Sponsors
HOLLT study project team
Eligibility
Inclusion criteria
Inclusion criteria: Adult male or females of age more than 18yrs who have suffered acute open fracture of tibia with severe soft tissue injury of gustilo grading 3b and 3c, Enrolment within 48hours of injury with commencement of HBO as soon as possible but not later than 48hrs, Permission to enrol of patient granted by trauma team,and Consent from patient or next of kin.
Exclusion criteria
Exclusion criteria: Other injuries,instability or intensive care requirements judged by trauma surgeon or incompatible with safe HBO. Patients suffering from advanced medical condition where severity of condition where follow up difficult. End stage PVD or other limb problems. Contraindications to HBO including pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Significant soft tissue necrosis defined on basis of amount of tissue surgically debrided after initial surgery. 2.Wound infection occurence occuring during acute phase will be dtermined according to USA CDC Guidelines for assessing surgical wound infections.Timepoint: occurence within 2 weeks of trauma of or both outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Early: a)Amputation, b)need of fasciotomy, c)time until wound closure d)breakdown of closed wounds e)number of operative procedures f) length of stay in ICU g) Length of stay in hospitalTimepoint: 2 months from injury;2) Late: Assessment will be made for soft tissue infection, osteomyelitis and wound complications,ability to bear wigth and for bone graft.Wound infections and osteomuelitis will be determined on same data collection and basis used for primary outcome. Return to work component of Sickness impact profile, a global disabilty scale and VAS will be incorporated. At 12months and 2yrs,SF36 questionnaire,lower limb injury component of SMFA assessment.Timepoint: 3,6,9,12,18,24 months. | — |
Countries
Australia, Austria, Canada, Czech Republic, India, Italy, Sweden
Contacts
Public ContactDrTarun Sahni
Outcome results
None listed