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Anterolateral Tigh (ALT) Flaps Oxygenation Monitoring by NIRS

ConditionsReconstructive Flap SurgeryFasciocutaneous Anterolateral Thigh FlapPostoperative MonitoringFlap Ischemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

refusal to provide written informed consent.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • clinical assessments and tissue oxygenation monitoring by Near Infrared Spectroscopy

    Diagnostic test

    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).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: patients with reconstructive flap surgery on upper or lower limb using a fasciocutanous tigh flap1 intervention

Trial outcomes

Primary outcomes

1

provide preliminary data on potential cut-off values for tissue oxygenation indicative for flap failure

a decrease of x percent in tissue oxygenation below the baseline value (first measurement upon arrival at the PACU) of the anterolateral thigh flap.

Time frame
from end of surgery untill five days after surgery
2

provide preliminary data on potential cut-off values for tissue oxygenation indicative for flap failure

a decrease of x percent in tissue oxygenation in the anterolateral thigh flap compared to the reference measurements obtained from the unaffected remaining anterolateral thigh.

Time frame
from end of surgery untill five days after surgery

Secondary outcomes

1

retrospective time-to-event analysis in patients with flap failure

a retrospective time-to-event analysis for the index test (NIRS measurements) and the reference test (the gold standard) within the subgroup of cases with flap failure.

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Antwerp

Lead sponsor

Source ClinicalTrials.gov
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