Detecting Tissue Ischemia in Reconstruction Flaps by a Novel CO2 Biosensor (DIMENSION-study)

Condition(s) studied

Investigational drug(s) / intervention(s)

IscAlert: Insertion of a CO2- and temperature sensor(s) in the reconstructed flap.

Study summary

The investigators will test if changes in CO2 is detected postoperatively in ischemic tissue in a reconstructed flap.

IscAlert is measuring continuously CO2 in muscular and subcutaneous tissue. IscAlert is inserted distal to the operative field into normal muscle and/or subcutaneous tissue in the reconstructed flap. Local tissue CO2 and temperature will be monitored continuously postoperatively until maximal 10 days.

If a reduced or totally obstructed blood flow appear (thrombosis), an increase in tissue CO2 and a lower local temperature will emerge rapidly as a sign of ischemia. This will be detected by the sensor which will alarm the investigators.

This will lead to assessment of the reconstructed flap and if restricted blood flow is diagnosed, a reoperation or other intervention will be performed. 56 patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the hospital or a maximum of 10 days (the event that occurs first). 360 devices are planned to be used in this clinical study.

Eligibility

Primary outcome measure(s)

• Tissue CO2-level — 10 days
  Tissue CO2-level (kPa) during insertion period

Trial sites (1)

More Oslo University Hospital trials in Norway

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