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Spectroscopic Assessment of Tissue Oxygenation Changes in Plastic Surgical Flap Reconstructions

25. august 2026 oppdatert av: Spectrocor
This study is a single-center, observational study designed to collect tissue spectrometric data.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Observe changes in flap tissue oxygenation
Tidsramme: 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.
From sensor placement until sensor removal minutes before completion of surgery (intraoperative period, approximately 2-6 hours)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of adverse events, adverse device effects, and device deficiencies
Tidsramme: 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.
From sensor placement during the operation until discharge from hospital (up to 30 days)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Spectrocor

Samarbeidspartnere

Helsinki University Central Hospital

Etterforskere

  • Hovedetterforsker: Patrik Lassus, PhD, Helsinki University Hospital (HUS)

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. juli 2031

Datoer for studieregistrering

Først innsendt

21. august 2026

Først innsendt som oppfylte QC-kriteriene

25. august 2026

Først lagt ut (Faktiske)

26. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SpC Flaps

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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