Spectroscopic Assessment of Tissue Oxygenation Changes in Plastic Surgical Flap Reconstructions
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Tommi Pätilä, PhD
- Número de telefone: +358 440130770
- E-mail: tommi@spectrocor.com
Estude backup de contato
- Nome: Kalle Kotilahti, PhD
- Número de telefone: +358449016550
- E-mail: kalle@spectrocor.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Observe changes in flap tissue oxygenation
Prazo: From sensor placement until sensor removal minutes before completion of surgery (intraoperative period, approximately 2-6 hours)
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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)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of adverse events, adverse device effects, and device deficiencies
Prazo: From sensor placement during the operation until discharge from hospital (up to 30 days)
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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.
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From sensor placement during the operation until discharge from hospital (up to 30 days)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Patrik Lassus, PhD, Helsinki University Hospital (HUS)
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SpC Flaps
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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