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Anterolateral Tigh (ALT) Flaps Oxygenation Monitoring by NIRS

NCT06744387 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-03-05

No results posted yet for this study

Summary

The goal of this observational study is to conduct postoperative monitoring in patients who have undergone upper or lower limb reconstructive surgery with an anterolateral thigh flap, by employing the gold standard approach: intermittent assessment of clinical parameters (flap's color, temperature, skin turgor and capillary refill time) combined with Doppler techniques, alongside continuous tissue oxygenation measurements obtained using the CASMED FORE-SIGHT ELITE monitor.The main objective of the study is to provide preliminary data on potential cut-off values indicative of flap failure.

Conditions

  • Reconstructive Flap Surgery
  • Fasciocutaneous Anterolateral Thigh Flap
  • Postoperative Monitoring
  • Flap Ischemia

Interventions

DIAGNOSTIC_TEST

clinical assessments and tissue oxygenation monitoring by Near Infrared Spectroscopy

Flap failure will be identified, based upon gold standard monitoring (flaps skin color, temperature, tissue turgor and capillary refill time) along with Doppler technique during a postoperative period of five days. In all patients Near Infrared Spectroscopy (NIRS) by FORE-SIGHT ELITE will be applied to obtain continuous tissue oxygenation measurements. NIRS values and trends from patients with flap failure (case group) will be compared to NIRS values and trends from patients with no flap failure(control group).

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2026-11-30
Completion
2026-12-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06744387 on ClinicalTrials.gov