Status:
RECRUITING
Detecting Tissue Ischemia in Reconstruction Flaps by a Novel CO2 Biosensor (DIMENSION-study)
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Sensocure AS
Conditions:
Ischemia
Blood Circulation Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. IscAl...
Detailed Description
This is an open, prospective, interventional, single-center clinical investigation designed to examine the feasibility and safety of the IscAlert™ device in patients scheduled for reconstructive flap ...
Eligibility Criteria
Inclusion Criteria:
- Patients must be scheduled for reconstructive flap surgery
- surgery
- Patients must be ≥ 18 years
- Patients must be able to give written signed informed consent
Exclusion Criteria:
• Another study interfering with current study
Key Trial Info
Start Date :
October 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05487820
Start Date
October 13 2023
End Date
October 1 2025
Last Update
March 25 2025
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0424