NCT06447610

Brief Summary

Lateral arm free flap harvesting has been well described, it however remains underused compared to other free flaps such as radial forearm and anterolateral thigh free flap. Due to its easy harvesting, low donor site morbidity, versatility as well as useful possibilities of modifications it should be considered more often as valuable reconstruction option in head and neck defect. With this publication we want to describe the operative technique, illustrate it with postoperative pictures and describe the outcome with 8 of our cases operated at University Hospital In Lausanne, Switzerland. The aim of this study is to be a useful tool for young surgeons and demonstrate the advantages of this useful flap in head and neck reconstructions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

June 3, 2024

Last Update Submit

June 3, 2024

Conditions

Keywords

Free flapsReconstructive surgeryMicrovascular surgerymaxillofacial surgery

Outcome Measures

Primary Outcomes (1)

  • Flap complication

    Description of free flap outcome: revision, complete or partial survival

    01.01.2021-12.01.2022

Secondary Outcomes (3)

  • Patient complication

    01.01.2021-12.01.2022

  • oral food intke

    01.01.2021-12.01.2022

  • revision of anastomoses

    01.01.2021-12.01.2022

Interventions

In this study, we present a case series of 8 patients operated for a maxillo-facial defect with a lateral arm free flap.

Eligibility Criteria

Age52 Years - 87 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Between 2021 and 2022, 8 patients (1 woman and 7 men) underwent reconstruction with a lateral arm free flap in Lausanne, Switzerland (Table 1). Their ages ranged from 52 to 87 years, with a mean age of 65.25 years. The reconstruction site varied from the exenterated orbita for two patients, internal cheek for two patients, retromolar mandible, palate, mouth floor and frontotemporal each for one patient. Reconstruction was done in all patients for oncologic reason. Six patients received primary reconstruction during the same surgery as the tumorectomy and for two patients' reconstruction was done in a second surgery.

You may qualify if:

  • \> 18 years old
  • operated between 01 january 2021 and 12 december 2022
  • lateral arm free flap operation for primary or secondary cervicofacial reconstruction
  • written informed consent

You may not qualify if:

  • minor patients
  • no written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV oral and maxillofacial surgery

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Study Officials

  • Laurence May, MD

    CHUV; oral and maxillofacial surgery , Lausanne, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 7, 2024

Study Start

December 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 29, 2024

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations