CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
NCT Number: NCT03915223
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Clermont-Ferrand, 63000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug) or physiological serum
Time frame: 2 days
measure of leg perimeter at the fractured area compared to the contralateral side
Time frame: 15 days
measure of leg perimeter at the fractured area compared to the contralateral side
Time frame: 7 days
measure of leg perimeter at the fractured area compared to the contralateral side
Time frame: preoperative
THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)
Time frame: 2 days
THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)
Time frame: 7 days
THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)
Time frame: 15 days
THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)
Time frame: 45 days
THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)
Time frame: 3 months
THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)
Time frame: 6 months
THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)
Time frame: 7 days
index form of follow-up the state cutaneous of the wound
Time frame: 15 days
index form of follow-up the state cutaneous of the wound
Time frame: 6 months
The Lower limb functional scale grading system uses 100 points to assess pain, function and mobility of the leg. The score varies between 0 and 100, more the value is better brought up is the score
Time frame: 6 months
list of the complications : Phlyctenes, scar disunity, cutaneous necrosis, infection, phlebitis, compartment syndrome, complex regional pain syndrome, delay of bone consolidation
University Hospital, Clermont-Ferrand
Other
Interest of Preoperative Corticosteroid Therapy for Surgical Fractures of the Lower Limb
Acronym: ICOMI
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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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