RecruitingNCT06744387

Anterolateral Tigh (ALT) Flaps Oxygenation Monitoring by NIRS

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


Sponsor

University Hospital, Antwerp

Enrollment

20 participants

Start Date

Mar 3, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • scheduled for reconstructive flap surgery on either upper or lower limb using a fasciocutaneous anterolateral thigh flap

Exclusion Criteria1

  • refusal to provide written informed consent.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTclinical 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06744387


Related Trials