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Recruiting Observational

The Research About Acute Compartment Syndrome

NCT04529330 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2019-01-01
Last updated
2021-08-04

Condition(s) studied

Acute Compartment Syndrome

Investigational drug(s) / intervention(s)

fasciotomy

fasciotomy: if it was suspected with ACS, the fasciotomy was conducted. but if the blister observed, it means decreased conmpartment sydrome. therefore, the blister observed can avoid unnecessary fasciotomy to patients suspected with ACS

Study summary

Acute compartment syndrome (ACS) is defined as a clinical entity originated from trauma or other conditions, and remains challenging to diagnose and treat effectively. Threre is the controversy in diagnosing, treating ACS. It was found that there was no criterion about the ACS, and result unnecessary osteotomy. The presence of clinical assessment (5P) always means the necrosis of muscles and was the most serious or irreversible stage of ACS. Besides pressure methods, the threshold of pressure identifying ACS was also controversial.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Fracture patients with Schatzker V and VI, * Who were older than eighteen years. Exclusion Criteria: * The exclusion criteria were pathologic, extra-articular proximal tibial fracture, * Patients who was eighteen years or younger. * Patients treated with other implant, * underwent conservative management were also excluded.

Primary outcome measure(s)

  • injury mechanism — up to 1 weeks
    The relative data was collected about injury mechanism such as high falling accident, traffic accident, fall from standing height,Crushing
  • the time when the blister appeared — up to 4 weeks
    The relative data was collected about the time when the blister appeared after injury
  • time to reconstructive surgery — time to when the surgery was conducted after 2 weeks
    The relative data was collected about time to reconstructive surgery
  • union time — through study completion, an average of 1 year
    The relative data was collected about union time
  • No non-anatomic gap or step (larger than 5 mm) — through study completion, an average of 1 year
    The relative data was collected about complications
  • secondary loss of reduction — through study completion, an average of 1 year
    The relative data was collected about complications
  • Deep venous thrombosis — through study completion, an average of 1 year
    The relative data was collected about complications
  • superficial wound problems — through study completion, an average of 1 year
    The relative data was collected about complications
  • blister skin immunochemistry and immunofluorescence analysis — through study completion, an average of 1 year
    CK1, 5, 10, claudin 1, 2 and occludin as determined by immunochemistry analysis, and skin barrier proteins; claudin 1, 2 and occludin was determined by immunofluorescence analysis and qPCR.

Trial sites (1)

FacilityCityRegionStatus
the Third Hospital of Hebei Medical University Shijiazhuang Hebei Recruiting

More Hebei Medical University Third Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04529330 on ClinicalTrials.gov ↗ ← All trials in China