MedTrace Logo

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

NCT05487820 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-01

No results posted yet for this 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.

Conditions

  • Ischemia
  • Blood Circulation Disorder
  • Biosensing Techniques
  • Surgery

Interventions

DEVICE

IscAlert

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

Sponsors & Collaborators

  • Sensocure AS

    collaborator INDUSTRY

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Magne Røkkum, MD, Ph.D · Oslo University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-13
Primary Completion
2025-05-30
Completion
2027-10-20

Countries

  • Norway

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05487820 on ClinicalTrials.gov