Postoperative perfusion monitoring of microvascular free flaps in head and neck reconstruction (early detection of perfusion impairment/free-flap complications after free tissue transfer).
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patients undergoing microvascular free flap reconstruction (myocutaneous/fasciocutaneous/osteomyocutaneous) with a skin paddle in the head and neck region. - Planned postoperative perfusion monitoring at the study site with feasibility to obtain the scheduled dermoscopic image acquisitions at predefined time points. -Written informed consent for study participation and pseudonymized image data acquisition/processing.
Exclusion criteria
Exclusion criteria: - No informed consent or withdrawal of consent / refusal to participate. - Inability to provide informed consent / lack of legal capacity (without permissible proxy consent per ethics approval). - Objection to scientific use of collected data/images. - Severe microangiopathy or relevant skin disease at/near the donor site (reference region) substantially limiting comparability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic/prognostic performance (ROC AUC) of the LLM total score (0–10) to predict clinically relevant perfusion impairment/complications of the microvascular free flap up to postoperative day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Agreement between the LLM score and the clinician perfusion score (e.g., ICC; optionally ? for categorical ratings). - Predictive value of individual flap regions (central/intermediate/peripheral/critical) for subsequent perfusion impairment/complications. - Predictive value of individual score components (e.g., color, hemoglobin component, capillary refill, temperature, healing status) for subsequent perfusion impairment/complications. - Added value of a reference region: comparison of predictive performance of LLM scoring with vs. without reference skin (e.g., ?AUC / model comparison). | — |
Countries
Germany
Contacts
Universitätsklinik und Poliklinik fürMund-, Kiefer- und Plastische Gesichtschirurgie