Detecting Ischemia After Replantation Surgery Using a Biosensor
Early Discovery of Ischemia After Replantation Surgery of the Extremities (EDIR-study) ; An Open, Prospective, Intervention Study
NA · Oslo University Hospital · NCT05297266
This study is testing a new device that monitors blood flow in patients who have had replant surgery on their arms or legs to see if it can help doctors catch problems early.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Oslo University Hospital (other) |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05297266 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the feasibility and safety of the IscAlert™ device in patients undergoing extremity replantation surgery. The device continuously monitors carbon dioxide levels and temperature in the replanted tissue to detect signs of ischemia, which may indicate restricted blood flow. If ischemia is detected, the device will alert the medical team for timely intervention, potentially leading to reoperation if necessary. The study will enroll sixty patients and utilize up to 400 sensors to gather data over a ten-day postoperative period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require extremity replantation surgery.
Not a fit: Patients who do not require extremity replantation surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the early detection of ischemia in replanted extremities, potentially reducing complications and improving patient outcomes.
How similar studies have performed: While the IscAlert device has shown promising results in animal studies, this approach is novel in the context of human extremity replantation surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be in need of extremity replantation surgery * Subject must be ≥ 18 years * Able to give written signed informed consent Exclusion Criteria: * None
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (RECRUITING)
Study contacts
- Principal investigator: Magne Røkkum, MD, Ph.D — Oslo University Hospital
- Study coordinator: Magne Røkkum, MD, Ph.D
- Email: mrokkum@ous-hf.no
- Phone: 23076025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemia, Blood Circulation Disorder, Carbon Dioxide, Biosensing Techniques, Amputation, Traumatic, Biosensor, Replantation, Carbon dioxide