Early Discovery of Ischemia After Replantation Surgery of the Extremities

NCT05297266 | Active Not Recruiting

• 1 other identifier: REK SØR-ØST B, ref 340841
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia; Blood Circulation Disorder; Carbon Dioxide; Biosensing Techniques; Amputation, Traumatic

Keywords

Ischemia; Biosensor; Replantation; Carbon dioxide; Traumatic amputation; Orthopedic surgery; Limb

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 replanted extremity

  10 days

• Number of re-operations

  30 days

Other Outcomes (8)

• Number of pack-years

  30 days

• Preoperative ischemia time

  12 hours

• Intravenous fluid

  12 hours

Study Arms (1)

Patients with replanted extremity monitored by tissue CO2

EXPERIMENTAL

Patients with traumatic amputation of a limb who are undergoing replantation surgery and are monitored postoperatively with IscAlert biosensor measuring local tissue CO2 and temperature in the replanted extremity

Device: IscAlert

Interventions

IscAlert DEVICE

Insertion of a CO2- and temperature sensor in the distal part of the replanted extremity

Patients with replanted extremity monitored by tissue CO2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be in need of extremity replantation surgery
• Subject must be ≥ 18 years
• Able to give written signed informed consent

You may not qualify if:

• None

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sensocure AS: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Ischemia; Amputation, Traumatic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Magne Røkkum, MD, Ph.D

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Prospective, interventional. Sixty patients (80 injured extremities) will receive tissue CO2 monitoring in the replanted extremity after traumatic amputation replant surgery.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: November 15, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)