Open tibial fractures MedDRA version: 14.1 Level: LLT Classification code 10030647 Term: Open fracture of unspecified part of tibia System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: oxígeno medicinal
Product Name: oxígeno
Pharmaceutical Form: Inhalation gas
Other descriptive name: OXYGEN
Concentration unit: % (V/V) percent volume/volume
Concentration type: equal
Conce
Sponsors
Hospital Universitario de Canarias
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether hyperbaric oxygen therapy in patients with open fracture of tibia grade II and III decreases the rate of surgical complications (necrosis, dehiscence, infection).;Primary end point(s): Decreased rates of surgical complications (necrosis, dehiscence, infection): necrosis or dehiscence are easy to measure. Describe the criteria for surgical site infection.;Secondary Objective: 1. To investigate whether hyperbaric oxygen increases the partial pressure of oxygen in the traumatized member. 2. To investigate whether hyperbaric oxygen reduces infection rates of fracture focus (deep infection). 3. To investigate whether this therapy reduces the rates of delayed union or nonunion. 4. To investigate whether this therapy reduces the number of amputations. 5. To investigate whether reducing the number of secondary procedures (soft tissue coverage, actions on the bone healing process). 6. To investigate whether decreases the overall average hospital stay;Timepoint(s) of evaluation of this end point: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 2,4 and 7 days;Secondary end point(s): Increased partial pressure of oxygen in the affected limb. We will evaluate whether hyperbaric oxygen actually produces an increase in oxygen delivery to traumatized tissue , for this, following Bouachour et al (19) will be measured partial pressure of oxygen by pulse oximetry in the affected limb in both patient groups at 2, 4 and 7 days of treatment. On the other hand, pulse oximetry would be conducted before and after hyperbaric oxygen therapy in the treatment group 2 (see Section 6.4). Deep infection rate (focus of fracture): The deep infection of the surgical site is one that affects the muscle fascia and subfascial tissues (muscle, bone, etc.).. If the infection affects both the surface and at depth, must be labeled as deep. A deep infection must meet at least one of the following requirements: a. Purulent drainage below the fascia. b. A deep incision that is open spontaneously or by the surgeon when the patient has at least one of the following signs or symptoms: fever (> 38 º C), or localized pain or tenderness, unless the culture of the incision is negative. c. An abscess or other evidence of infection affecting the deep incision is at the direct examination of the wound or during reoperation, or by histopathological or radiological study. d. Diagnosis of deep surgical site infection by the surgeon or physician. Rate of fracture healing at 3, 6 and 9 months: radiological consolidation of the fracture is defined as evidence of bone trabeculae pass or consolidation of all cortical least two orthogonal projections (anteroposterior and lateral in our trial). The clinical healing was defined as the carrying capacity without pain at the fracture site. The definition of nonunion of the fracture of the tibia is surprisingly difficult. The mean union time of the open fracture of the tibia is significantly higher than the closed fracture. Following authors like Court-Brown et al. ( | — |
Countries
Spain
Contacts
Public ContactMario Herrera
Hospital Universitario de Canarias
Outcome results
None listed