Monitoring oxygen levels in thigh flap surgeries
Tissue Oxygenation Monitoring of Anterolateral Thigh (ALT) Flaps, Using FORE-SIGHT ELITE Near InfraRed Spectroscopy (NIRS) - A Pilot Study
This study is testing a new way to monitor oxygen levels in patients who have had thigh flap surgery to see if it can help doctors spot problems with the flap sooner.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT06744387 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor patients who have undergone reconstructive surgery using an anterolateral thigh flap. It combines traditional clinical assessments of the flap's condition with continuous tissue oxygenation measurements using Near Infrared Spectroscopy (NIRS). The goal is to gather preliminary data on potential indicators of flap failure, enhancing postoperative care and intervention timing. By employing a more objective monitoring approach, the study seeks to improve the reliability of flap assessments during the critical postoperative phase.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for reconstructive flap surgery on either the upper or lower limb using a fasciocutaneous anterolateral thigh flap.
Not a fit: Patients who refuse to provide written informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring techniques that reduce the risk of flap failure in reconstructive surgeries.
How similar studies have performed: While the use of NIRS for monitoring tissue oxygenation is established, this specific application in flap surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * scheduled for reconstructive flap surgery on either upper or lower limb using a fasciocutaneous anterolateral thigh flap Exclusion Criteria: * refusal to provide written informed consent.
Where this trial is running
Edegem, Antwerp
- Antwerp University Hospital — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Study coordinator: Vera Saldien, MD
- Email: vera.saldien@uza.be
- Phone: 38214788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.