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

Primary Purpose

Polytraumatises With Rib Fractures

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Thoracic osteosyntheses with Stracos
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polytraumatises With Rib Fractures

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital University of PoitiersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Surgical treatment with Stracos

Medical treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Average cost hospitalization
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

length of hospital stays of the intensive care department
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
From the first day to the last day in the hospital
occurence of pulmonary infection
The vital capacity (VC)
Volume measurement (L)
The expiratory reserve volume (ERV)
Volume measurement (L)
The total lung capacity (TLC)
Volume measurement (L)
Residual volume (RV)
Volume measurement (L)
6 min walk test (6MWT)
Distance measurement (M)
Visual analog scorer for pain
Patient Global Assessment to measure quality of life
date of return to work

Full Information

First Posted
November 22, 2015
Last Updated
April 4, 2019
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02635165
Brief Title
Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos
Acronym
EMVOLS
Official Title
Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polytraumatises With Rib Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment with Stracos
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Medical treatment
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Thoracic osteosyntheses with Stracos
Primary Outcome Measure Information:
Title
Average cost hospitalization
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
length of hospital stays of the intensive care department
Description
From the first day to the last day in the intensive care department. Care department - monitoring patients with traumatic hemothorax - lung pulmonary infectious associated -
Time Frame
4 weeks
Title
length of hospital stays
Description
From the first day to the last day in the hospital
Time Frame
4 weeks
Title
occurence of pulmonary infection
Time Frame
12 months of follow up
Title
The vital capacity (VC)
Description
Volume measurement (L)
Time Frame
visit 3 months, visit 6 months, visit 12 months after the surgery
Title
The expiratory reserve volume (ERV)
Description
Volume measurement (L)
Time Frame
visit 3 months, visit 6 months, visit 12 months after the surgery
Title
The total lung capacity (TLC)
Description
Volume measurement (L)
Time Frame
visit 3 months, visit 6 months, visit 12 months after the surgery
Title
Residual volume (RV)
Description
Volume measurement (L)
Time Frame
visit 3 months, visit 6 months, visit 12 months after the surgery
Title
6 min walk test (6MWT)
Description
Distance measurement (M)
Time Frame
visit 3 months, visit 6 months, visit 12 months after the surgery
Title
Visual analog scorer for pain
Time Frame
at visit 7 days, 28 days, 3 months, 6 months and 12 months
Title
Patient Global Assessment to measure quality of life
Time Frame
at visit 7 days, 28 days, 3 months, 6 months and 12 months
Title
date of return to work
Time Frame
visit 3 months, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe CJ JAYLE, PI
Phone
05.49.44.30.07
Email
christophe.jayle@chu-poitiers.fr
Facility Information:
Facility Name
Hospital University of Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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