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Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos (EMVOLS)

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ClinicalTrials.gov Identifier: NCT02635165
Recruitment Status : Unknown
Verified April 2019 by Poitiers University Hospital.
Recruitment status was:  Recruiting
First Posted : December 18, 2015
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Polytraumatises With Rib Fractures Device: Thoracic osteosyntheses with Stracos Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos
Study Start Date : November 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Surgical treatment 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.
 Device: Thoracic osteosyntheses with Stracos
No Intervention: Medical treatment


Outcome Measures
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Primary Outcome Measures :
  1. Average cost hospitalization [ Time Frame: 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 :
  1. length of hospital stays of the intensive care department [ Time Frame: 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 -

  2. length of hospital stays [ Time Frame: 4 weeks ]
    From the first day to the last day in the hospital

  3. occurence of pulmonary infection [ Time Frame: 12 months of follow up ]
  4. The vital capacity (VC) [ Time Frame: visit 3 months, visit 6 months, visit 12 months after the surgery ]
    Volume measurement (L)

  5. The expiratory reserve volume (ERV) [ Time Frame: visit 3 months, visit 6 months, visit 12 months after the surgery ]
    Volume measurement (L)

  6. The total lung capacity (TLC) [ Time Frame: visit 3 months, visit 6 months, visit 12 months after the surgery ]
    Volume measurement (L)

  7. Residual volume (RV) [ Time Frame: visit 3 months, visit 6 months, visit 12 months after the surgery ]
    Volume measurement (L)

  8. 6 min walk test (6MWT) [ Time Frame: visit 3 months, visit 6 months, visit 12 months after the surgery ]
    Distance measurement (M)

  9. Visual analog scorer for pain [ Time Frame: at visit 7 days, 28 days, 3 months, 6 months and 12 months ]
  10. Patient Global Assessment to measure quality of life [ Time Frame: at visit 7 days, 28 days, 3 months, 6 months and 12 months ]
  11. date of return to work [ Time Frame: visit 3 months, 6 months and 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635165


Contacts
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Contact: Christophe CJ JAYLE, PI 05.49.44.30.07 christophe.jayle@chu-poitiers.fr

Locations
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France
Hospital University of Poitiers Recruiting
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
More Information
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02635165    
Other Study ID Numbers: 2014-A01844-43
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Rib Fractures
Flail Chest
Fractures, Bone
Wounds and Injuries
Thoracic Injuries