Reconstructive SurgeryNCT06447610
Lateral Arm Free Flap: a Useful Flap in the Maxillo-facial Surgeon's Therapeutic Armory, Case Series
An observational study of Reconstructive Surgery, run by CHUV chirurgie orale et maxillofaciale at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 52 to 87 years
- Conditions the study is for
- Reconstructive Surgery
- What is being tested?
- Lateral arm free flap
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2023to 29 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 52 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- > 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
Who cannot join
- minor patients
- no written informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
CHUV oral and maxillofacial surgery
Lausanne, Canton of Vaud, 1011
About this study
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.
- Conditions
- Reconstructive Surgery
- Being tested
- Lateral arm free flap
- Keywords
- Free flaps, Reconstructive surgery, Microvascular surgery, maxillofacial surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral arm free flapProcedure or surgery
In this study, we present a case series of 8 patients operated for a maxillo-facial defect with a lateral arm free flap.
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap complication
Description of free flap outcome: revision, complete or partial survival
Measured: 01.01.2021-12.01.2022
Secondary outcomes (3)
Patient complication
general complcation such as cardiac, pulmonary, neurologic complcation
Measured: 01.01.2021-12.01.2022
oral food intke
days after surgery when oral food intake is allowed
Measured: 01.01.2021-12.01.2022
revision of anastomoses
secondary look for patency of anastomoses because of free flap suffering
Measured: 01.01.2021-12.01.2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Dec 2023
- Primary completion1 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstructive SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHUV chirurgie orale et maxillofaciale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence May, MD, Principal investigator, CHUV; oral and maxillofacial surgery , Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447610
- Sponsor's protocol ID
- lateral arm 1
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Arm Free Flap: a Useful Flap in the Maxillo-facial Surgeon's Therapeutic Armory, Case Series
- ClinicalTrials.gov ID
- NCT06447610
- Acronym / sponsor ID
- lateral arm 1
- Conditions
- Reconstructive Surgery
- Keywords
- Free flaps, Reconstructive surgery, Microvascular surgery, maxillofacial surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- CHUV chirurgie orale et maxillofacialeUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 52 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- > 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
Key exclusion criteria (2 listed)
- minor patients
- no written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral arm free flapIn this study, we present a case series of 8 patients operated for a maxillo-facial defect with a lateral arm free flap. | Procedure or surgery | – |
Primary outcome
Flap complication
Time frame: 01.01.2021-12.01.2022
Description of free flap outcome: revision, complete or partial survival
3 secondary outcomes
Patient complication
Time frame: 01.01.2021-12.01.2022
oral food intke
Time frame: 01.01.2021-12.01.2022
revision of anastomoses
Time frame: 01.01.2021-12.01.2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence May, MD principal investigator
CHUV; oral and maxillofacial surgery , Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reconstructive Surgery, run by CHUV chirurgie orale et maxillofaciale at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flap complication (time frame: 01.01.2021-12.01.2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.