Lip InjuryNCT04974918
The Reliability and Versatility of Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip Defects
A study testing Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection. in people with Lip Injury, run by Sohag University.
Trial summary
Nasolabial flaps have limited mobility and may need two stages, mostly for intraoral defects .The facial artery perforator-based flap is the first true perforator flap in the face. It allows one-stage reconstruction and allows freedom in flap design. Read more about this study
- Who is it for?
- Ages 7 to 70 years
- Conditions the study is for
- Lip Injury
- What is being tested?
- Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2021to 30 Dec 2022
- 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 7 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Lip defect more than half of lip
- Patients aging 7 to 70 years
Who cannot join
- Lip defect less than half of lip
- Patients with a major uncontrollable medical illness, chronic heavy smokers
Trial locations and contacts
No sites are listed yet.
Ahmed Gaber Ahmed, MD contact
About this study
Nasolabial flaps have limited mobility and may need two stages, mostly for intraoral defects .The facial artery perforator-based flap is the first true perforator flap in the face. It allows one-stage reconstruction and allows freedom in flap design.
The nasolabial perforator flap has certain advantages such as repair using a similar tissue, a wider rotation arc around the pedicle compared to the other regional flaps, and the primary closure of the donor area.
Read the detailed description
Recently, perforator flaps have become popular in many areas of reconstructive surgery. They provide design freedom and reduce donor-site morbidity. Many traditional local flaps including nasolabial flaps are based on the use of the axial facial artery with multiple perforators. Flaps based on one perforator of the facial artery have been introduced and are used more frequently because of their advantages over perforator flaps.
According to recent literatures, facial artery provides numerous cutaneous perforators, on which skin flaps can be islanded, with greater mobility and liability for reconstruction of small-to-moderate-sized intraoral and facial defects in one stage. .
Multiple perforators along the facial artery, a mean of 4 on each half of the face (range: 2-8), with a mean diameter of 0.94 mm (range: 0.53-1.36 mm) and maximum perforators between 20 and 60 mm from the origin along the length of the facial artery. This roughly corresponds to an area near the angle of the mouth around the nasolabial fold. A local skin flap based on such perforators can be islanded, with greater freedom in flap designing for reconstruction of small-to-moderate-sized intraoral and facial defects in one stage Ethical consideration This study will be approved by the ethics committee of Faculty of Medicine Sohag University. A written informed consent will be taken from every patient that will be included in this study and all patients will be informed about the nature \& the aim of the study and the possibility of any complication.
Surgical technique:
After tumor ablation the facial artery perforator along the nasolabial fold was found and marked with a handheld Doppler probe. A perforator near the defect was selected to accomplish a sufficient arc of rotation without tension. The flap was designed to cover the defect based on one perforator and to hide the donor site in the nasolabial fold. An incision on one side of the flap was made to the subcutaneous tissue. Undermining of the flap until the perforators were identified. After the perforators were identified, the flap was redesigned and an incision was made circumferentially. Dissection of the pedicle was performed until tension-free transposition was done to cover the defect, and the distal perforators were sacrificed to help flap movement. For protection against shear forces, the investigators left a small cuff of subcutaneous fat around the perforator
- Conditions
- Lip Injury
- Being tested
- Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection.Procedure or surgery
A perforator near the defect was selected to accomplish a sufficient arc of rotation without tension. The flap was designed to cover the defect based on one perforator and to hide the donor site in the nasolabial fold. An incision on one side of the flap was made to the subcutaneous tissue. Undermining of the flap until the perforators were identified. After the perforators were identified, the flap was redesigned and an incision was made circumferentially. Dissection of the pedicle was performed until tension-free transposition was done to cover the defect, and the distal perforators were sacrificed to help flap movement.
| Study group | Role | What they receive |
|---|---|---|
| Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip defects | Experimental | participants will be chosen according to liable age and information will be given about complications Receives: Procedure: Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of donor site scar
the possibility of a one-stage reconstruction and customization. In addition, the use of this flap increases aesthetic results, as it uses a local flap and conceals the donor scar within a natural fold.
prevent furthur operations for reconstructions. We use( 0..100 visual analog scale) to show change of skin texture to basal line as 0 is the worst result and 100 the best ...patient questionnaire about the result will be done
Measured: one year
Secondary outcomes (1)
change of lip size
as other procedures may cause microstomia and affect speech
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start30 Jul 2021 (estimated)
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lip InjuryStudies 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, Aya Ahmed Ahmed, Sohag University
- Investigators
- Gamal Yossef Elsayed, MD, Study chair, sohag university , Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974918
- Sponsor's protocol ID
- Soh-Med-21-07-07
- Status last verified
- Aug 2021
- First submitted
- 16 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ercan A, Ercan LD, Demiroz A. Nasolabial Perforator Flap: A Multi-Tool for Reconstruction of Facial Units. J Craniofac Surg. 2020 Jun;31(4):1042-1045. doi: 10.1097/SCS.0000000000006285.
PubMed 32168126
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Versatility of Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip Defects
- ClinicalTrials.gov ID
- NCT04974918
- Acronym / sponsor ID
- Soh-Med-21-07-07
- Conditions
- Lip Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 23 Jul 2021 (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.
Nasolabial flaps have limited mobility and may need two stages, mostly for intraoral defects .The facial artery perforator-based flap is the first true perforator flap in the face. It allows one-stage reconstruction and allows freedom in flap design.
The nasolabial perforator flap has certain advantages such as repair using a similar tissue, a wider rotation arc around the pedicle compared to the other regional flaps, and the primary closure of the donor area.
Detailed description
Recently, perforator flaps have become popular in many areas of reconstructive surgery. They provide design freedom and reduce donor-site morbidity. Many traditional local flaps including nasolabial flaps are based on the use of the axial facial artery with multiple perforators. Flaps based on one perforator of the facial artery have been introduced and are used more frequently because of their advantages over perforator flaps.
According to recent literatures, facial artery provides numerous cutaneous perforators, on which skin flaps can be islanded, with greater mobility and liability for reconstruction of small-to-moderate-sized intraoral and facial defects in one stage. .
Multiple perforators along the facial artery, a mean of 4 on each half of the face (range: 2-8), with a mean diameter of 0.94 mm (range: 0.53-1.36 mm) and maximum perforators between 20 and 60 mm from the origin along the length of the facial artery. This roughly corresponds to an area near the angle of the mouth around the nasolabial fold. A local skin flap based on such perforators can be islanded, with greater freedom in flap designing for reconstruction of small-to-moderate-sized intraoral and facial defects in one stage Ethical consideration This study will be approved by the ethics committee of Faculty of Medicine Sohag University. A written informed consent will be taken from every patient that will be included in this study and all patients will be informed about the nature \& the aim of the study and the possibility of any complication.
Surgical technique:
After tumor ablation the facial artery perforator along the nasolabial fold was found and marked with a handheld Doppler probe. A perforator near the defect was selected to accomplish a sufficient arc of rotation without tension. The flap was designed to cover the defect based on one perforator and to hide the donor site in the nasolabial fold. An incision on one side of the flap was made to the subcutaneous tissue. Undermining of the flap until the perforators were identified. After the perforators were identified, the flap was redesigned and an incision was made circumferentially. Dissection of the pedicle was performed until tension-free transposition was done to cover the defect, and the distal perforators were sacrificed to help flap movement. For protection against shear forces, the investigators left a small cuff of subcutaneous fat around the perforator
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip defects | Experimental | Procedure: Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection.participants will be chosen according to liable age and information will be given about complications |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Lip defect more than half of lip
- Patients aging 7 to 70 years
Key exclusion criteria (2 listed)
- Lip defect less than half of lip
- 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 |
|---|---|---|
| Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection.A perforator near the defect was selected to accomplish a sufficient arc of rotation without tension. The flap was designed to cover the defect based on one perforator and to hide the donor site in the nasolabial fold. An incision on one side of the flap was made to the subcutaneous tissue. Undermining of the flap until the perforators were identified. After the perforators were identified, the flap was redesigned and an incision was made circumferentially. Dissection of the pedicle was performed until tension-free transposition was done to cover the defect, and the distal perforators were sacrificed to help flap movement. | Procedure or surgery | Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip defects |
Primary outcome
change of donor site scar
Time frame: one year
the possibility of a one-stage reconstruction and customization. In addition, the use of this flap increases aesthetic results, as it uses a local flap and conceals the donor scar within a natural fold. prevent furthur operations for reconstructions. We use( 0..100 visual analog scale) to show change of skin texture to basal line as 0 is the worst result and 100 the best ...patient questionnaire about the result will be done
1 secondary outcome
change of lip size
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Results publication: PubMed 32168126Ercan A, Ercan LD, Demiroz A. Nasolabial Perforator Flap: A Multi-Tool for Reconstruction of Facial Units. J Craniofac Surg. 2020 Jun;31(4):1042-1045. doi: 10.1097/SCS.0000000000006285.
- 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.
Ahmed Gaber Ahmed, MD contact
Gamal Yossef Elsayed, MD study chair
sohag university , Egypt
Questions about this trial
What is this clinical trial studying?
A study testing Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection. in people with Lip Injury, run by Sohag University.
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 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Aya Ahmed Ahmed, resident (01125473647, aya.abdelmawgod@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of donor site scar (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04974918, which also lists 1 linked publication.
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 9 Aug 2021.