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Flap IschemiaNCT07786610

Spectroscopic Assessment of Tissue Oxygenation Changes in Plastic Surgical Flap Reconstructions

An observational study of Flap Ischemia and Hypoxia, run by Spectrocor.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a single-center, observational study designed to collect tissue spectrometric data. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Flap Ischemia, Hypoxia
How many people
30 participants
Where
No sites listed yet
Study dates
1 Dec 2026to 31 Jul 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients scheduled for plastic surgical reconstructive flap operation in the Helsinki University Central Hospital.

Who may be able to join

  • Adults, age of 18 - 90 years
  • Scheduled for plastic surgical reconstructive flap operation
  • Ability and willingness to provide informed consent.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Tommi Pätilä, PhD contact

+358 440130770

tommi@spectrocor.com

Kalle Kotilahti, PhD contact

+358449016550

kalle@spectrocor.com

About this study

This study is a single-center, observational study designed to collect tissue spectrometric data.

Read the 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.

Keywords
tissue oxygenation, cytochrome c oxidase, intraoperative monitoring, near-infrared spectroscopy, medical device
Medical subject headings
Hypoxia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Observe changes in flap tissue oxygenation

    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.

    Measured: From sensor placement until sensor removal minutes before completion of surgery (intraoperative period, approximately 2-6 hours)

Secondary outcomes (1)

  1. Incidence of adverse events, adverse device effects, and device deficiencies

    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.

    Measured: From sensor placement during the operation until discharge from hospital (up to 30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Jul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07786610
Sponsor's protocol ID
SpC Flaps
Status last verified
Aug 2026
First submitted
21 Aug 2026
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. Participant consent and the approved Clinical Investigation Plan do not cover secondary sharing of individual-level data, and the sponsor's obligations under Regulation (EU) 2016/679 (GDPR) preclude onward transfer without a valid legal basis. Aggregate results will be published in accordance with the publication policy and made publicly available in EUDAMED, and the clinical investigation report will be submitted to the competent authority within one year of the end of the investigation.

Publications

  • Keller A. Noninvasive tissue oximetry for flap monitoring: an initial study. J Reconstr Microsurg. 2007 May;23(4):189-97. doi: 10.1055/s-2007-974655.

    PubMed 17530610

  • Keller A. A new diagnostic algorithm for early prediction of vascular compromise in 208 microsurgical flaps using tissue oxygen saturation measurements. Ann Plast Surg. 2009 May;62(5):538-43. doi: 10.1097/SAP.0b013e3181a47ce8.

    PubMed 19387157

  • Steele MH. Three-year experience using near infrared spectroscopy tissue oximetry monitoring of free tissue transfers. Ann Plast Surg. 2011 May;66(5):540-5. doi: 10.1097/SAP.0b013e31820909f9.

    PubMed 21301288

  • Chen Y, Shen Z, Shao Z, Yu P, Wu J. Free Flap Monitoring Using Near-Infrared Spectroscopy: A Systemic Review. Ann Plast Surg. 2016 May;76(5):590-7. doi: 10.1097/SAP.0000000000000430.

    PubMed 25664408

  • Tran PC, DeBrock W, Lester ME, Hartman BC, Socas J, Hassanein AH. The False Positive Rate of Transcutaneous Tissue Oximetry Alarms in Microvascular Breast Reconstruction Rises after 24 Hours. J Reconstr Microsurg. 2021 Jun;37(5):453-557. doi: 10.1055/s-0040-1719048. Epub 2020 Oct 31.

    PubMed 33129214

  • Schoenbrunner A, Hackenberger PN, DeSanto M, Chetta M. Cost-Effectiveness of Vioptix versus Clinical Examination for Flap Monitoring of Autologous Free Tissue Breast Reconstruction. Plast Reconstr Surg. 2021 Aug 1;148(2):185e-189e. doi: 10.1097/PRS.0000000000008154.

    PubMed 34133372

  • Sultan DL, Atamian E, Tarr J, Feingold R, Kasabian AK, Tanna N, Smith ML, Moon V. A Prospective Cohort Study Re-examining Tissue Oximetry Monitoring in Microsurgical Breast Reconstruction. Ann Plast Surg. 2023 Jun 1;90(6):580-584. doi: 10.1097/SAP.0000000000003555. Epub 2023 May 9.

    PubMed 37157150

  • Ali J, Cody J, Maldonado Y, Ramakrishna H. Near-Infrared Spectroscopy (NIRS) for Cerebral and Tissue Oximetry: Analysis of Evolving Applications. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2758-2766. doi: 10.1053/j.jvca.2021.07.015. Epub 2021 Jul 10.

    PubMed 34362641

Questions about this trial

What is this clinical trial studying?

An observational study of Flap Ischemia and Hypoxia, run by Spectrocor.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tommi Pätilä, PhD (+358 440130770, tommi@spectrocor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observe changes in flap tissue oxygenation (time frame: From sensor placement until sensor removal minutes before completion of surgery (intraoperative period, approximately 2-6 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07786610, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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