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Clinical Trial

Early Discovery of Ischemia After Replantation Surgery of the Extremities

NCT: NCT05297266 · ACTIVE_NOT_RECRUITING

NCT IDNCT05297266
StatusACTIVE_NOT_RECRUITING
Start Date2022-11-15
Completion2027-09-30

Brief Summary

Investigators will test if changes in CO2 is detected postoperatively in ischemic tissue in a replanted extremity of a traumatically amputated upper or lower extremity. 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 replanted extremity. Local tissue CO2 and temperature will be monitored continuously postoperatively for the next 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 replanted extremity and if restricted blood flow is diagnosed, a reoperation will be performed. After reoperation new sensors will be implanted for another ten days if applicable. Sixty 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). 500 devices is planned to be used in this clinical study.

Frequently Asked Questions

What is Early Discovery of Ischemia After Replantation Surgery of the Extremities?

Early Discovery of Ischemia After Replantation Surgery of the Extremities is a clinical trial registered under NCT05297266. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT05297266?

The current status of NCT05297266 (Early Discovery of Ischemia After Replantation Surgery of the Extremities) is: ACTIVE_NOT_RECRUITING.

When did Early Discovery of Ischemia After Replantation Surgery of the Extremities start?

Early Discovery of Ischemia After Replantation Surgery of the Extremities started on 2022-11-15.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.