Monitoring of wound and fracture healing and prediction of non-union via measurements of microcirculatio

• Conditions: S82; S42; Fracture of lower leg, including ankle; Fracture of shoulder and upper arm

• Registration Number: DRKS00031942
• Lead Sponsor: niversität des Saarlandes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-22
• Results First Posted: 2023-09-25
• Study Completion: 2024-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Bone fracture (Tibia, clavicle, patella)
Ability for written and verbal informed consent

Exclusion Criteria

Underage
Inabilita to give consent

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RHb, SO2 and tissue blood flow at 3, 8, 10, 12, 14 and 16 mm depth. NIRS parameters O2Hb, HHb, tHb, HbDiff und TSI. In addition skin temperature.

Secondary Outcome Measures

Name	Time	Method
1. effect of i.v. administration of noradrenaline on perfusion in the fracture gap, <br>2. to assess whether the measurement can be made only in the fracture gap or also 2 cm away from it,<br>3. clarification of whether microcirculation measurements can be used to predict the development of pseudarthrosis,<br>4. definition of the physiological changes in the above parameters in the course of fracture healing.