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

NCT05487820 | Active Not Recruiting

• 1 other identifier: DIMENSION
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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. 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; Biosensing Techniques; Surgery; Blood Circulation Disorder

Keywords

Ischemia; Biosensor; Reconstructive; Surgery; Carbon dioxide; Flap

Outcome Measures

Primary Outcomes (1)

• Tissue CO2-level

  Tissue CO2-level (kPa) during insertion period

  10 days

Secondary Outcomes (5)

• Bleeding

  10 days

• Infection

  30 days

• Length of stay at hospital

  30 days

• Time to reduced blood flow in reconstructed flap

  30 days

• Number of re-operations

  30 days

Other Outcomes (16)

• Number of pack-years

  30 days

• Warm ischemia time

  12 hours

• Intravenous fluid

  12 hours

Study Arms (1)

Patients with reconstructed flap monitored by tissue CO2

EXPERIMENTAL

Patients scheduled for reconstructive flap surgery are monitored postoperatively with IscAlert biosensor measuring local tissue CO2 and temperature in the reconstructed flap

Device: IscAlert

Interventions

IscAlert DEVICE

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

Patients with reconstructed flap monitored by tissue CO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be scheduled for reconstructive flap surgery
• surgery
• Patients must be ≥ 18 years
• Patients must be able to give written signed informed consent

You may not qualify if:

• Another study interfering with current study

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sensocure AS: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Magne Røkkum, MD, Ph.D

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, interventional. Hundred-and-sixty (56) patients will receive tissue CO2 monitoring in a reconstructed flap after reconstructive flap surgery.

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: October 13, 2023
• Primary Completion: May 30, 2025
• Study Completion (Estimated): October 20, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)