Flap Assessment With Regional Oximetry for Early Detection of Compromise in Free Flap Reconstructive Surgery - FLARE Study

NCT07887256 | Not Yet Recruiting FDA Device

• 2 other identifiers: NL-010821P26.023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

After some operations in which tissue is removed, it is necessary to repair the defect with a piece of tissue from another location in the body. This is called a microsurgically transplanted tissue flap (or tissue flap, for short). It is important that, after an operation, enough blood flows to the relocated tissue. In this study, we want to investigate whether, after the operation, measuring oxygen in the tissue flap with the INVOS 7100c device helps detect blood flow problems earlier. In the future, this could help doctors intervene more quickly, thereby reducing the risk of complications.

Conditions

Reconstructive Surgery; Flap Monitoring

Keywords

DIEP; INVOS; Reconstructive surgery; Free flap surgery; Near-infrared spectroscopy; Flap monitoring

Outcome Measures

Primary Outcomes (1)

• Proportion successfully maintained monitor

  The proportion of patients (%) in whom continuous tissue oximetry monitoring was successfully maintained for the entire postoperative period.

  From day of surgery (day 0) until day 3 postoperative

Secondary Outcomes (9)

• Surgical re-exploration

  From day of surgery (day 0) until day 3 postoperative

• Flap failure

  From day of surgery (day 0) until day 3 postoperative

• Flap risk score

  From day of surgery (day 0) until day 3 posteroperative

• Postoperative complications

  From day of surgery (day 0) until day 3 posteroperative

• INVOS risk triggers: absolute drop of StO₂

  From start of INVOS measurements (day 0) until day 3 postoperative

Other Outcomes (2)

• Reasons of device failure

  From day of surgery (day 0) until day 3 postoperative

• Patient satisfaction

  At day 3 postoperative

Study Arms (1)

Primary cohort

Adult patients scheduled for elective free flap reconstructive surgery.

Procedure: Elective free flap surgery; Device: INVOS monitoring

Interventions

Elective free flap surgery PROCEDURE

Reconstruction using deep inferior epigastric perforator (DIEP) flap. Participants will receive standard surgical, anaesthetic and postoperative care according to local practice.

Primary cohort

INVOS monitoring DEVICE

The INVOS system (In Vivo Optical Spectroscopy). INVOS™ sensors will be applied to the free flap and to a femoral reference site for postoperative tissue oximetry monitoring. The INVOS™ monitor readings will not be visible to caregivers, alarms will be muted, and INVOS™ measurements will not be used for clinical decision-making during this study. Clinical assessment and Doppler monitoring will remain leading for all decisions regarding flap viability.

Primary cohort

Eligibility Criteria

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

Study Population

Patients scheduled for elective free flap reconstructive surgery

You may qualify if:

• Patients 18 years or older who are schedulded for elective free flap reconstructive surgery

You may not qualify if:

• Severe cardiac comorbidities (NYHA heart failure \>2)
• Severe pulmonary comorbidities (MET\<4)
• Oxygen saturation level \< 90% without supplemental oxygen during preop visit
• Any contraindications for INVOStm monitoring
• Inability or refusal to complete informed consent form
• Absence of an adequate site for safe and reliable INVOS™ sensor placement on or near the free flap, or for placement of the reference sensor, as determined by the treating plastic surgeon

Sponsors & Collaborators

• Leiden University Medical Center: lead
• HagaZiekenhuis: collaborator
• Medtronic: collaborator
• Medical Center Haaglanden: collaborator

Study Sites (3)

Leiden University Medical Centre

Leiden, South Holland, 2333 ZA, Netherlands

Location

Haaglanden Medisch Centrum, locatie Anthoniushove

Leidschendam, South Holland, 2262 BA, Netherlands

Location

HagaZiekenhuis

The Hague, South Holland, 2545 AA, Netherlands

Location

Related Publications (6)

• Lindelauf AAMA, Vranken NPA, Rutjens VGH, Schols RM, Heijmans JH, Weerwind PW, van der Hulst RRWJ. Economic Analysis of Noninvasive Tissue Oximetry for Postoperative Monitoring of Deep Inferior Epigastric Perforator Flap Breast Reconstruction: A Review. Surg Innov. 2020 Oct;27(5):534-542. doi: 10.1177/1553350620942985. Epub 2020 Jul 23.

  PMID: 32701027 BACKGROUND

• Whitaker IS, Pratt GF, Rozen WM, Cairns SA, Barrett MD, Hiew LY, Cooper MA, Leaper DJ. Near infrared spectroscopy for monitoring flap viability following breast reconstruction. J Reconstr Microsurg. 2012 Mar;28(3):149-54. doi: 10.1055/s-0031-1296030. Epub 2011 Nov 30.

  PMID: 22131106 BACKGROUND

• Salgarello M, Pagliara D, Rossi M, Visconti G, Barone-Adesi L. Postoperative Monitoring of Free DIEP Flap in Breast Reconstruction with Near-Infrared Spectroscopy: Variables Affecting the Regional Oxygen Saturation. J Reconstr Microsurg. 2018 Jul;34(6):383-388. doi: 10.1055/s-0038-1636527. Epub 2018 Apr 19.

  PMID: 29672776 BACKGROUND

• Kagaya Y, Miyamoto S. A systematic review of near-infrared spectroscopy in flap monitoring: Current basic and clinical evidence and prospects. J Plast Reconstr Aesthet Surg. 2018 Feb;71(2):246-257. doi: 10.1016/j.bjps.2017.10.020. Epub 2017 Nov 22.

  PMID: 29175135 BACKGROUND

• Kumbasar DE, Hagiga A, Dawood O, Berner JE, Blackburn A. Monitoring Breast Reconstruction Flaps Using Near-Infrared Spectroscopy Tissue Oximetry. Plast Surg Nurs. 2021 Apr-Jun 01;41(2):108-111. doi: 10.1097/PSN.0000000000000380.

  PMID: 34033637 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

Study Officials

• Martijn Boon, MD, PhD

  Leiden University Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martijn Boon, MD, PhD

CONTACT

0031 71 526 2301; m.boon@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

NL (3)