Soft Part Management for Surgical Fractures of the Lower Limb
NCT ID: NCT03915223
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2019-05-10
2024-05-06
Brief Summary
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Detailed Description
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The effect corticosteroids (anti-edema and anti-inflammatory) is used in neurosurgery and maxillofacial surgery.
So, it seemed judicious to evaluate the effectiveness of corticosteroids in bolus preoperatively in order to limit the importance of the edema before intervention to prevent adverse effect of the edema on the cicatrization.
This study will aim to confirm this indication or not on the contrary to change current practices.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm "Injection corticosteroids"
Single dose of Solumedrol 2 mg/kg
leg fracture
Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum
Arm " injection physiological serum"
Single dose of physilogical serum
leg fracture
Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum
Interventions
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leg fracture
Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum
Eligibility Criteria
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Inclusion Criteria
* Patient covered by the social security system
* Patient giving informed consent
Exclusion Criteria
* Multiple trauma,
* Pathological fracture on primary or secondary lesions,
* Pre-existing bone disease (excluding osteoporosis) of the operated limb,
* Diabetes,
* Pre-existing trophic disorders on one of the 2 lower limbs,
* Long-term corticotherapy,
* Pathology of the pituitary-adrenal axis,
* Any other contraindication to glucocorticoids: any infectious condition, some developing viral diseases (including hepatitis, herpes, chicken pox, shingles), hypersensitivity to one of the constituents
* Hypernatremia and hypochloremia
* Pre-existing severe cardiac injury
* Contraindication to TegadermTM
* Patient placed under guardianship, tutorship or safeguard of justice,
* Pregnant or lactating women,
18 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Stéphane Boisgard
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Other Identifiers
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2018-003565-33
Identifier Type: OTHER
Identifier Source: secondary_id
RBHP 2018 BOISGARD
Identifier Type: -
Identifier Source: org_study_id
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