Soft Part Management for Surgical Fractures of the Lower Limb

• Status: Recruiting
• Trial end date: 2022-05-10
• Target enrollment: 0
• Participant gender: All

Summary

The assessment consists in comparing corticoids injection versus placebo in surgery of lower limb fractures The aim of study is to assess (state cutaneous, efficacy, safety) corticoids injection on a prospective, randomized analysis

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Anti-Inflammatory Agents; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Patient over the age of 18, hospitalized in the Orthopedics Department for a leg fracture (ankle, tibia: proximal, diaphysis, distal) requiring surgery within 72 hours of the trauma

• Patient covered by the social security system

• Patient giving informed consent

Exclusion Criteria:

• Open fracture with infectious risks cauchoix 2 and 3

• 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,