NCT03915223

Soft Part Management for Surgical Fractures of the Lower Limb

Interest of Preoperative Corticosteroid Therapy for Surgical Fractures of the Lower Limb

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

One of the major problems of below-knee fractures is edema (delaying surgery time and post-operative complications for healing). 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

• Leg Injuries
• Fracture
• Edema

Interventions

Type	Name	Description
PROCEDURE	leg fracture	Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum

Timeline

• Start date: 2019-05-10
• Primary completion: 2023-12-25
• Completion: 2024-05-06
• First posted: 2019-04-16
• Last updated: 2024-05-08

Locations

1 site across 1 country: France