Use of a Non-ICU Specialty Ward For Immediate Post-operative Management of Head and Neck Free Flaps

NCT03340038 | Completed

• 1 other identifier: 841511
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing free flap reconstructive surgery at University of California, Davis Medical Center (UCDMC) will be assigned randomly into no intervention group (immediate post operative care in an ICU) or intervention group (immediate post operative care in a non-ICU specialty ward). The investigators hypothesize that there is no significant difference in the length of stay (LOS) or complication rate between head and neck free flaps patients managed immediately post-operatively in an ICU versus a non-ICU specialty ward. The primary objective is to compare the postoperative LOS between head and neck free-flap patients managed initially in an ICU versus a non-ICU specialty ward. The secondary objective is to compare differences in the rate of complications between head and neck free flap patients managed initially in an ICU versus a non-ICU specialty ward. Finally, the tertiary objective is to compare differences in resource utilization between head and neck free-flap patients managed initially in an ICU versus a non-ICU specialty ward.

Conditions

Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Head and Neck Carcinoma; Trauma

Keywords

Free Flap Reconstructive Surgery; Head and Neck

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  Number of days

  30 days

Secondary Outcomes (1)

• Inpatient Hospital Costs (dollar amounts)

  30 days

Other Outcomes (2)

• Post Operative Complication Rate

  30 days

• Medical Complications

  30 days

Study Arms (2)

Specialty Ward

ACTIVE COMPARATOR

Patients who have been randomized into receiving post-operative care at the Non-ICU Specialty ward (intervention) after receiving flap reconstructive surgery on their mucosal or cutaneous defect.

Other: Non-ICU Specialty ward

Intensive Care Unit (ICU)

NO INTERVENTION

Patients who have been randomized into receiving post-operative care at the intensive care unit after receiving flap reconstructive surgery on their mucosal or cutaneous defect.

Interventions

Non-ICU Specialty ward OTHER

Specialty Ward

Eligibility Criteria

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

You may qualify if:

• Patients undergoing free flaps for reconstruction of head and neck surgical defects at UCDMC, including but not limited to, head and neck cancer defects, osteoradionecrosis (ORN), and trauma
• years of age and older and able to consent

You may not qualify if:

• Vulnerable populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Wounds and Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Arnaud Bewley, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Co-Director of Head and Neck Surgery Fellowship Director of Microvascular Reconstruction

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: April 10, 2016
• Primary Completion: February 11, 2019
• Study Completion: April 16, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

US (1)