NSAID
DrugWill be used if tolerated.
Other names: Diclofenac, Naprosyn, Ibuprofen
NCT Number: NCT02132416
The purpose of this prospective controlled study is to determine whether surgical management of unstable thoracic cage injuries and chest wall deformity in trauma reduces the need for and the time spent on ventilator compared to a group treated without operation.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Departement of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
Patients meeting the inclusion criteria and giving their informed consent will be enrolled in this prospective controlled study. Included patients at Sahlgrenska University Hospital will undergo surgical stabilization of chest wall injuries and patients at Karolinska University Hospital will be managed conservatively. A total of 60 patients will be included in each group. 3D reconstructions of computed tomography images of the Thorax done at admission to the hospital will be used in order to evaluate injury according to Lung Injury Scale and Chest wall Injury Scale and for calculating radiological lung volumes and plan surgical procedure in the intervention group. Surgery will be performed as soon as possible after inclusion. MatrixRIB® (DePuy Synthes) Fixation system is used for stabilizing rib fractures with plates and angular locked screws. In cases where thoracotomy is done the patients will receive an anterior and posterior chest tube and wound drain with active suction. All patients, both in the intervention and in the control group will be offered thoracic epidural anaesthesia. Broad-spectrum intravenous antibiotic therapy is given as long as the patient has chest tubes. Thrombotic prophylaxis with LMWH is given until the patient is mobilized but for a minimum of 7 days. Patients will be followed-up 6 weeks, 6 months and 1 year post-operatively by surgeon and physiotherapist. A low-dosage computer tomography of the thorax will be done after 6 months in order to evaluate healing of the rib cage, possible non-union or dysfunction of osteosynthetic material and measure remaining lung volume. This examination will be compared to the initial computer tomography image done when the patient was admitted. At follow-ups complaints, possible late complications, usage of analgesia and return to work will be recorded. Evaluated instruments, EQ-5D-5L, VAS with Pain-O-Meter (POM) and Disability Rating Index (DRI) will be used to evaluate quality of life, pain and physical function. Range of motion in the thorax, thoracic spine and shoulders will be evaluated for every patient. Breathing movements will be measured by using a Respiratory movement measuring instrument (RMMI, ReMo Inc) and lung function tests will be performed in a standardized manner.
In order to enrich the material, hospital data from patients fulfilling the inclusion criteria but not included, at the two study locations, during the inclusion period (June 2014 - June 2017) will be analyzed. An additional Ethical approval has been granted.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Will be used if tolerated.
Other names: Diclofenac, Naprosyn, Ibuprofen
Initially intravenous administration and when tolerated oral slow-release pils will be used.
Other names: Tramadol, Oxycodone, Morphine
Given by specialists in anaesthesiology and intensive care.
Other names: Continous thoracic epidural anaesthesia will be offered.
1g QID will be given to all patients unless allergies.
Other names: Paracet, Alvedon, Panodil
Fracture stabilization
Other names: Matrix Rib Fixation System (DePuy Synthes).
Time frame: 1 year
Need and length of ventilation therapy
Time frame: 6 weeks
Time spent in an intensive care unit and total length of hospital stay
Time frame: 1 year
Pain, function and mobility
Time frame: Time Frame
EQ-5D-5L instrument has a subscale of; 1 (no problems), 2 (slight problems), 3 (moderate problems), 4 (severe problems) and 5 (extreme problems). The Visual Analogue scale is a self-rating scale from 0% (the worst Health you can imagine) to 100% (the best Health you can imagine).
Sahlgrenska University Hospital
Other
Prospective Controlled Study of Surgical Management of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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