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NCT Number: NCT07295548

Postoperative Management of Patients Undergoing Head and Neck Microvascular Free Flap Reconstructive Surgery: is Admission to an Intensive Care Unit Necessary?

The aim of our study is to assess if patients undergoing head and neck free flap reconstructive surgery admitted to the ICU have equivalent postoperative outcomes to those admitted to an Otolaryngology specialty ward

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location status: Recruiting

Location contact

Simone Mauramati

CONTACT

[email protected]

+39 3668734310

About this study

Reconstruction with microvascular free flaps has become the standard of care for various surgical defects in head and neck region. Free flap reconstructive surgery is considered a major surgery with long intraoperative time and critical post-operative care. Close monitoring of the flap viability is of utmost importance especially in the first 48-72 hours after surgery, during which most of the vascular complications could occur; this interval is also critical for eventual successful salvage of an ischemic flap. Despite the delicacy of the matter worldwide there's not yet consensus about which is the most appropriate protocol for postoperative management after free flap surgery. Many patients undergoing free flap surgery are initially admitted to intensive care unit (ICU), even in cases of patients that do not meet any specific indication supporting the need for admission to an ICU setting. There are several reasons to this behaviour but, unfortunately, a post-operative stay in ICU is associated with increased nosocomial infections, complications and costs. The primary aim of this study will be to assess safety and postoperative outcomes (major and minor complications, flap failure rates and length of hospital stay) of patients undergoing reconstructive surgery with microvascular free flaps admitted to ICU compared to a non-ICU ward.The primary objective is to identify in which group of patients minor complications are more frequently encountered (complications that do not require surgical treatment in the operating room are considered as minor).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Free Flap surgery

Procedure

evaluation of major and minor complications, flap failure rates and length of hospital stay in patients undergoing free flap surgery admitted to intensive care unit and in those admitted to an Otolaryngology specialty ward

Primary outcomes

  1. difference in proportions of minor complications in the two groups of patients

    Time frame: up to 24 months

    the difference in proportions of minor complications in the two groups of patients (ICU compared to a nonICU ward)

Secondary outcomes

  1. difference in proportions of major complications and necrosis in the two groups of patients

    Time frame: up to 24 months

    the difference in proportions of major complications and necrosis in the two groups of patients (ICU compared to a nonICU ward).

  2. difference in length of hospitalisation in the two groups of patients

    Time frame: up to 24 months

    the difference in length of hospitalisation in the two groups of patients (ICU compared to a non ICU ward)

Study contacts

Contact information is provided by the study sponsor or research team.

Simone Mauramati

CONTACT

[email protected]

+39 3668734310

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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