Flap Ischemia, Hypoxia
Conditions
Keywords
tissue oxygenation, cytochrome c oxidase, intraoperative monitoring, near-infrared spectroscopy, medical device
Brief summary
This study is a single-center, observational study designed to collect tissue spectrometric data.
Detailed description
A total of 30 participants aged 18 or older, with a planned plastic surgical reconstructive flap operation, will be recruited in this investigation. The primary purpose is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor peripheral tissue oxygenation perioperatively. The investigation is designed as an open, non-controlled observational study with the primary goal of assessing the devices' ability to monitor and observe tissue oxygenation and safety in routine operation, reflecting the real-world patient population and treatment scenarios. Therefore, no control group is needed in this investigation. In this study, the SpectroCor Tissue Oxygenation Monitoring is used to observe flap viability during and after plastic surgical reconstruction. SpectroCor sensor is inserted into the reconstructed flap or into the subcutaneous tissue in the distal wound to observe and collect data on tissue oxygenation. During the procedure, the flap tissue undergoes an ischemic period during microsurgical anastomosis, followed by reperfusion upon release of the vascular clamp. During the reconstructive flap surgery, spectroscopic data of tissue oxygenation are collected and compared to the recorded tissue saturation levels and to occurring events, procedures, and clinical parameters.
Interventions
None listed
Sponsors
Spectrocor
Helsinki University Central Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adults, age of 18 - 90 years * Scheduled for plastic surgical reconstructive flap operation * Ability and willingness to provide informed consent.
Exclusion criteria
* Unable to provide signed informed consent * Considered a vulnerable person according to the Finnish Medical Research Act (488/1999), Chapter 2, Sections 7, 9, and 10, including retarded persons, pregnant women, nursing mothers, prisoners, and forensic patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observe changes in flap tissue oxygenation | From sensor placement until sensor removal minutes before completion of surgery (intraoperative period, approximately 2-6 hours) | To observe the changes in flap tissue oxygenation (combined hemoglobin/myoglobin saturation, %) measured by the SpectroCor Monitoring System during the ischemia-reperfusion sequence of microvascular flap reconstruction. Continuous spectroscopic measurement of combined hemoglobin and myoglobin oxygen saturation in the transferred flap tissue, recorded from a SpectroCor Sensor inserted into the flap, with a second sensor placed in subcutaneous tissue of the distal wound. Saturation values are time-stamped against intraoperative events affecting flap perfusion (pedicle division and flap detachment from the donor site, completion of the microvascular anastomosis, release of the vascular clamp and reperfusion, and any anastomotic revision) and compared with paired arterial and venous blood gas samples obtained at the beginning and at the end of the surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events, adverse device effects, and device deficiencies | From sensor placement during the operation until discharge from hospital (up to 30 days) | Number and proportion of participants experiencing at least one adverse event (AE), adverse device effect (ADE), serious adverse event (SAE), serious adverse device effect (SADE), or unanticipated serious adverse device effect (USADE), and the number of device deficiencies (DD) recorded. Events are recorded from the time of sensor placement until discharge from hospital and assessed for causal relationship to the investigational device by the investigator. Anticipated device-related events include topical bleeding at the sensor attachment site, local tissue reaction associated with tissue glue fixation, and local infection at the insertion site. |
Contacts
CONTACTTommi Pätilä, PhD
CONTACTKalle Kotilahti, PhD
PRINCIPAL_INVESTIGATORPatrik Lassus, PhD
Helsinki University Hospital (HUS)
Outcome results
None listed