Anterolateral Tigh (ALT) Flaps Oxygenation Monitoring by NIRS

NCT06744387 | Recruiting

• 1 other identifier: EDGE 003917
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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.

  from end of surgery untill five days after surgery

• 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.

  from end of surgery untill five days after surgery

Secondary Outcomes (1)

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

  through study completion, an average of 1 year

Study Arms (1)

patients with reconstructive flap surgery on upper or lower limb using a fasciocutanous tigh flap

Diagnostic Test: clinical assessments and tissue oxygenation monitoring by Near Infrared Spectroscopy

Interventions

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).

patients with reconstructive flap surgery on upper or lower limb using a fasciocutanous tigh flap

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• refusal to provide written informed consent.

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

Central Study Contacts

Vera Saldien, MD

CONTACT

38214788; vera.saldien@uza.be

Study Design

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

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 20, 2024
• Study Start: March 3, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)