Postoperative care after head and neck free flap reconstruction: ICU versus Otolaryngology ward
Postoperative Management of Patients Undergoing Head and Neck Microvascular Free Flap Reconstructive Surgery: is Admission to an Intensive Care Unit Necessary?
This study will see if patients who go to the ICU after head and neck free flap reconstruction have similar complication rates, flap success, and hospital stays as patients cared for on an Otolaryngology specialty ward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 192 (estimated) |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07295548 on ClinicalTrials.gov |
What this trial studies
This is an observational comparison of postoperative outcomes for patients undergoing head and neck reconstructive surgery with microvascular free or pedicled flaps who are admitted either to the ICU or to an Otolaryngology specialty ward at a single center. The study will record major and minor complications, flap failure rates, and length of hospital stay, with particular attention to the first 48–72 hours when vascular complications are most likely. Investigators will compare rates of nosocomial infection, need for flap salvage, and resource use between the two care pathways. Results aim to clarify which patients truly need ICU-level monitoring versus safe ward-based care.
Who should consider this trial
Good fit: Adults undergoing head and neck oncologic resection with reconstruction using free or pedicled flaps at Fondazione IRCCS Policlinico San Matteo in Pavia are the ideal candidates for this study.
Not a fit: Patients who do not receive flap reconstruction (for example those treated only with radiation or systemic therapy) or those with clear clinical indications for ICU-level care are unlikely to benefit from the comparisons in this study.
Why it matters
Potential benefit: If successful, the findings could reduce unnecessary ICU admissions, lower infection risk and costs, and help direct appropriate postoperative monitoring to the right patients.
How similar studies have performed: Some prior observational studies and center protocols have suggested selected free-flap patients can be safely managed outside the ICU, but evidence is mixed and no broad consensus exists.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients undergoing Head and Neck oncological demolitive surgery and reconstruction using free or pedicled flaps at the Fondazione IRCCS Policlinico San Matteo, Pavia Exclusion Criteria: * patients treated for Head and Neck cancer without flap reconstruction (e.g., only chemotherapy-radiotherapy, only radiotherapy, only immunotherapy).
Where this trial is running
Pavia, Lombardy
- Fondazione IRCCS Policlinico San Matteo — Pavia, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Simone Mauramati
- Email: s.mauramati@smatteo.pv.it
- Phone: +39 3668734310
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.