Reconstruction of Head Soft Tissue DefectsNCT05727150
Reliability and Versatility of Supraclavicular Artery Flap in Reconstruction of Head and Neck Soft Tissue Defects
A study testing Reconstruction of Soft tissue defects of head and neck by Supraclavicular artery flap in people with Reconstruction of Head Soft Tissue Defects and Reconstruction of Neck Soft Tissue Defects, run by Sohag University at 1 site in Egypt.
Trial summary
This is a case series study conducted at plastic surgery department Sohag University including 20 patients The aim of this thesis is to evaluate reliability and versatility of Supraclavicular artery flap in the reconstruction of traumatic and non-traumatic defects of head and neck.With adequate documentation of… Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- Reconstruction of Head Soft Tissue Defects, Reconstruction of Neck Soft Tissue Defects
- What is being tested?
- Reconstruction of Soft tissue defects of head and neck by Supraclavicular artery flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2023to Jan 2024
- Phase
- Interventional
- 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 5 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with head and neck soft tissue defect either traumatic or non-traumatic
- Available healthy donor site
Who cannot join
- Trauma or conditions affecting donor site or with possible compromise of vascular pedicle.
- Patients with a major uncontrollable medical illness, chronic heavy smokers.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag Faculty of Medicine
Sohag
Ahmad A Albadry, 201110884856, ahmedahmed@med.sohag.edu.eg
Karam A Mohammed, 201021777543, Karam.allam@med.sohag.edu.eg
About this study
This is a case series study conducted at plastic surgery department Sohag University including 20 patients The aim of this thesis is to evaluate reliability and versatility of Supraclavicular artery flap in the reconstruction of traumatic and non-traumatic defects of head and neck.With adequate documentation of functional, aesthetic outcome and patient satisfaction through; clinical examination , photographic documentation and doctor and patient satisfaction charts
- Being tested
- Reconstruction of Soft tissue defects of head and neck by Supraclavicular artery flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstruction of Soft tissue defects of head and neck by Supraclavicular artery flapProcedure or surgery
Supraclavicular artery flap will be used in the reconstruction of traumatic and non-traumatic defects of head and neck.Flap harvesting and reconstruction will be performed under general anesthesia. The defect dimensions are measured and the superficial landmarks for the supraclavicular artery are drawn .The flap will be used as island flap, transposed or interpolated flap depending on the arc of rotation needed to achieve flap inset without tension and flap elevation proceeds from lateral to medial.The flap is rotated and inset into the defect
| Study group | Role | What they receive |
|---|---|---|
| Patient operated by Supraclavicular Artery flap for Reconstruction | Experimental | Supraclavicular artery flap will be used for reconstruction Receives: Procedure: Reconstruction of Soft tissue defects of head and neck by Supraclavicular artery flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap Success
The flap success will be measured by percentage of patients in which there is flap survival versus percentage of patient with flap necrosis
Measured: 6 month post-surgery
Flap complications
assessment of flap complication will be assessed by percentage of patients in which there is flap dehiscence , flap infection and flap necrosis
Measured: 6 months post-surgery
patients satisfaction as regard flap color match
patient satisfaction as will be assessed with questionnaire
Measured: 6 months post-surgery
patients satisfaction as regard flap texture match
patient satisfaction as will be assessed with questionnaire
Measured: 6 months post-surgery
Secondary outcomes (2)
Possible flap lengths
The achieved flap length will be measured in centimeters
Measured: 6 months post-surgery
Possible flap widths
The achieved flap width will be measured in centimeters
Measured: 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reconstruction of Head Soft Tissue DefectsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Ahmad Albadry, Sohag University
- Investigators
- Ahmad A Albadry, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727150
- Sponsor's protocol ID
- Soh-Med-23-01-03
- Status last verified
- Feb 2023
- First submitted
- 22 Jan 2023
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Versatility of Supraclavicular Artery Flap in Reconstruction of Head and Neck Soft Tissue Defects
- ClinicalTrials.gov ID
- NCT05727150
- Acronym / sponsor ID
- Soh-Med-23-01-03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 14 Feb 2023 (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.
This is a case series study conducted at plastic surgery department Sohag University including 20 patients The aim of this thesis is to evaluate reliability and versatility of Supraclavicular artery flap in the reconstruction of traumatic and non-traumatic defects of head and neck.With adequate documentation of functional, aesthetic outcome and patient satisfaction through; clinical examination , photographic documentation and doctor and patient satisfaction charts
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient operated by Supraclavicular Artery flap for Reconstruction | Experimental | Procedure: Reconstruction of Soft tissue defects of head and neck by Supraclavicular artery flapSupraclavicular artery flap will be used for reconstruction |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with head and neck soft tissue defect either traumatic or non-traumatic
- Available healthy donor site
Key exclusion criteria (2 listed)
- Trauma or conditions affecting donor site or with possible compromise of vascular pedicle.
- Patients with a major uncontrollable medical illness, chronic heavy smokers.
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 |
|---|---|---|
| Reconstruction of Soft tissue defects of head and neck by Supraclavicular artery flapSupraclavicular artery flap will be used in the reconstruction of traumatic and non-traumatic defects of head and neck.Flap harvesting and reconstruction will be performed under general anesthesia. The defect dimensions are measured and the superficial landmarks for the supraclavicular artery are drawn .The flap will be used as island flap, transposed or interpolated flap depending on the arc of rotation needed to achieve flap inset without tension and flap elevation proceeds from lateral to medial.The flap is rotated and inset into the defect | Procedure or surgery | Patient operated by Supraclavicular Artery flap for Reconstruction |
Primary outcome
Flap Success
Time frame: 6 month post-surgery
The flap success will be measured by percentage of patients in which there is flap survival versus percentage of patient with flap necrosis
Flap complications
Time frame: 6 months post-surgery
assessment of flap complication will be assessed by percentage of patients in which there is flap dehiscence , flap infection and flap necrosis
patients satisfaction as regard flap color match
Time frame: 6 months post-surgery
patient satisfaction as will be assessed with questionnaire
patients satisfaction as regard flap texture match
Time frame: 6 months post-surgery
patient satisfaction as will be assessed with questionnaire
2 secondary outcomes
Possible flap lengths
Time frame: 6 months post-surgery
Possible flap widths
Time frame: 6 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: Undecided
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.
Ahmad A Albadry principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconstruction of Soft tissue defects of head and neck by Supraclavicular artery flap in people with Reconstruction of Head Soft Tissue Defects and Reconstruction of Neck Soft Tissue Defects, run by Sohag University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 14 Feb 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad A Albadry (20111088856, ahmedahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flap Success (time frame: 6 month post-surgery). The study lists 4 primary outcomes in all. 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 14 Feb 2023.