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RECRUITING
NCT06744387

Anterolateral Tigh (ALT) Flaps Oxygenation Monitoring by NIRS

Sponsor: University Hospital, Antwerp

View on ClinicalTrials.gov

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.

Official title: Tissue Oxygenation Monitoring of Anterolateral Thigh (ALT) Flaps, Using FORE-SIGHT ELITE Near InfraRed Spectroscopy (NIRS) - A Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2025-03-03

Completion Date

2026-12-30

Last Updated

2025-03-05

Healthy Volunteers

No

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).

Locations (1)

Antwerp University Hospital

Edegem, Antwerp, Belgium