Spectroscopic Assessment of Tissue Oxygenation Changes in Plastic Surgical Flap Reconstructions

NCT07786610 | Not Yet Recruiting

• 1 other identifier: SpC Flaps
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Flap Ischemia; Hypoxia

Keywords

tissue oxygenation; cytochrome c oxidase; intraoperative monitoring; near-infrared spectroscopy; medical device

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Incidence of adverse events, adverse device effects, and device deficiencies

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spectrocor: lead
• Helsinki University Central Hospital: collaborator

Related Publications (8)

• 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.

  PMID: 17530610 BACKGROUND

• 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.

  PMID: 19387157 BACKGROUND

• 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.

  PMID: 21301288 BACKGROUND

• 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.

  PMID: 25664408 BACKGROUND

• 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.

  PMID: 33129214 BACKGROUND

• 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.

  PMID: 34133372 BACKGROUND

• 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.

  PMID: 37157150 BACKGROUND

• 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.

  PMID: 34362641 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrik Lassus, PhD

  Helsinki University Hospital (HUS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommi Pätilä, PhD

CONTACT

+358 440130770; tommi@spectrocor.com

Kalle Kotilahti, PhD

CONTACT

+358449016550; kalle@spectrocor.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2031
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share