Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos
- Conditions
- Polytraumatises With Rib Fractures
- Interventions
- Device: Thoracic osteosyntheses with Stracos
- Registration Number
- NCT02635165
- Lead Sponsor
- Poitiers University Hospital
- Brief Summary
Optimize the management of polytraumatises with flail chest: surgical treatment Stracos by decreasing the length of stay and the late complications: pain chronicles, quality of life, respiratory function
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 310
- Patients with flail chest including bifocal fracture of three or more consecutive ribs in at least two places with or without paradoxical movement
- The surgical procedure was performed in the first 48 hours after admission
- pathology with prognosis for survival 6-month-old inferior
- Paraplegia or Tetraplegia
- Patients having the necessity of neurosurgical treatment or reanimation of neurosurgical
- Aorta hematoma or rupture
- ß-HCG positive in women
- titanium allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgical treatment with Stracos Thoracic osteosyntheses with Stracos The patient was placed in the lateral decubitus position. The procedure involved a curvilinear thoracic incision overlying the center of the fractured segments. The intercostal muscles were dissected off the rib on its superior aspect away from the fracture site, and the fracture was then reduced. The investigators then chose the most suitable Stracos, which is to be found in two available sizes, 6 or 9 claws, according to the length of the fracture. The clip chosen was molded according to the shape of the corresponding rib and the claws were crimped using special pliers on and around the fractured rib.The investigators treated only one rib out of two with Stracos, and as for displaced or comminuted fractures, the adjacent rib was wrapped using vicryl suture on the osteosynthesis rib.
- Primary Outcome Measures
Name Time Method Average cost hospitalization 4 weeks Average cost hospitalization without the intensive care cost.The cost of the hospitalization will be calculated by adding the cost of the surgery and hospital stay- time of the surgery-The number of Stracos used by patient
- Secondary Outcome Measures
Name Time Method The vital capacity (VC) visit 3 months, visit 6 months, visit 12 months after the surgery Volume measurement (L)
length of hospital stays of the intensive care department 4 weeks From the first day to the last day in the intensive care department. Care department - monitoring patients with traumatic hemothorax - lung pulmonary infectious associated -
length of hospital stays 4 weeks From the first day to the last day in the hospital
The expiratory reserve volume (ERV) visit 3 months, visit 6 months, visit 12 months after the surgery Volume measurement (L)
Patient Global Assessment to measure quality of life at visit 7 days, 28 days, 3 months, 6 months and 12 months date of return to work visit 3 months, 6 months and 12 months occurence of pulmonary infection 12 months of follow up The total lung capacity (TLC) visit 3 months, visit 6 months, visit 12 months after the surgery Volume measurement (L)
Residual volume (RV) visit 3 months, visit 6 months, visit 12 months after the surgery Volume measurement (L)
6 min walk test (6MWT) visit 3 months, visit 6 months, visit 12 months after the surgery Distance measurement (M)
Visual analog scorer for pain at visit 7 days, 28 days, 3 months, 6 months and 12 months
Trial Locations
- Locations (1)
Hospital University of Poitiers
🇫🇷Poitiers, France