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

Launched by OSLO UNIVERSITY HOSPITAL · Aug 2, 2022

Keywords

ClinConnect Summary

The DIMENSION study is a clinical trial that is exploring a new way to monitor blood flow in patients who have surgery to reconstruct a part of their body using a "flap" of tissue. Researchers are using a special device called IscAlert to continuously measure the carbon dioxide (CO2) levels in the tissue after surgery. If the blood flow to the flap becomes limited or blocked, the device will detect an increase in CO2 and a drop in temperature, which are early signs of a problem called ischemia. This allows the medical team to respond quickly and take necessary actions, such as a reoperation, if needed.

To be eligible for this trial, participants must be at least 18 years old and scheduled for reconstructive flap surgery. They also need to be able to understand and sign a consent form. The trial is currently recruiting a total of 56 patients, and they can expect to have the IscAlert device monitoring them for up to 10 days after their surgery. Before leaving the hospital, the device will be safely removed. This study aims to improve the care and outcomes for patients undergoing this type of surgery by catching potential problems early.

Gender

ALL

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