MeningoceleNCT05188300
Propellers Flaps for Meningomylocele Defects
A study testing Freestyle pedicled perforators propellers flaps for meningomyelocele defects in people with Meningocele and Meningomyelocele, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate reliability of free style propeller perforator flap for coverage MMC soft tissue defect follow a well-established step that overcome the usual problem of pedicled perforators propellers flaps. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Meningocele, Meningomyelocele
- What is being tested?
- Freestyle pedicled perforators propellers flaps for meningomyelocele defects
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Nov 2021
- 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 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All cases with dorsolumbar meningomyelocele and age up to 6 months
Who cannot join
- Infants older than 6 months
- concomitant congenital anomalies
- concomitant spinal kyphosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Free Style Pedicled Perforators Propellers Flaps for Meningomylocele Defects Reconstruction With Sequential Advance in Perforators Dissection
To evaluate reliability of free style propeller perforator flap for coverage MMC soft tissue defect follow a well-established step that overcome the usual problem of pedicled perforators propellers flaps.
Read the detailed description
Meningomyelocele is a serious congenital birth defect that not only affect mortality and morbidity of neonate but also a lifelong health problem.
The estimated incidence of spina bifida is 1-2 cases per 1000 population. Meningomylocele soft tissue defect reconstruction is considered a lifesaving procedure , the ideal coverage technique should be time limited , reliable and allow healing line to be away from repair of the dura . all of these criteria are available in the selection of free style propeller perforator flap as a method of reconstruction.
- Conditions
- Meningocele, Meningomyelocele
- Being tested
- Freestyle pedicled perforators propellers flaps for meningomyelocele defects
- Keywords
- Reconstructive Surgical Procedures / adverse effects, Meningomyelocele / surgery
- Medical subject headings
- Meningocele, Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freestyle pedicled perforators propellers flaps for meningomyelocele defectsProcedure or surgery
Freestyle pedicled perforators propellers flaps for meningomyelocele defects reconstruction with sequential advance in perforators dissection, large number cases, and detailed successful technique.
| Study group | Role | What they receive |
|---|---|---|
| Dorsal intercostal artery (DICA) perforator flaps | Experimental | Retrograde dissection of free style perforator arising from DICA according to region of dorsal spine and identification of paraspinal muscle where perforator vessel was found Receives: Procedure: Freestyle pedicled perforators propellers flaps for meningomyelocele defects |
| Trapezius musculocutaneous perforator flaps | Experimental | Retrograde dissection of a free style perforator arising as a trapezius myocutenous perforator where the trapezius muscle is identified and a perforator vessel was isolated. Receives: Procedure: Freestyle pedicled perforators propellers flaps for meningomyelocele defects |
| Lumbar artery perforators flaps | Experimental | Retrograde dissection of free style perforator arising from lumbar artery according to region of lumbar spine and identification of lumbar fascia where perforator vessel was found Receives: Procedure: Freestyle pedicled perforators propellers flaps for meningomyelocele defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of reconstruction technique
Measure the average operative time in minutes in each arm.
Measured: Time of procedure
Pedicle dissection beyond the muscle
Compare the number of pedicle dissection beyond the muscle in each group.
Measured: Time of procedure
Secondary outcomes (1)
Meningomyelocele Repair Dehiscence and/or CSF leak
Compare the number of each complication in each arm
Measured: Time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Jan 2019
- Primary completion1 Oct 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MeningoceleStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel-Tawab Mohamed, Assiut University
- Investigators
- Mohamed K Kamel, Principal investigator, Assiut UniversityAwni M Shawkat, MD, Study chair, Assiut UniversityMahmoud A Mohamed, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188300
- Sponsor's protocol ID
- propellers flap
- Status last verified
- Dec 2021
- First submitted
- 26 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kushida-Contreras BH, Gaxiola-Garcia MA. Myelomeningocele defect reconstruction with keystone flaps: vascular rationale for the design and operative technique. Arch Plast Surg. 2021 May;48(3):254-260. doi: 10.5999/aps.2020.01746. Epub 2021 May 15.
PubMed 34024069Formentin C, de Andrade EJ, Matias LG, Joaquim AF, Tedeschi H, Raposo-Amaral CE, Ghizoni E. Using the keystone design perforator island flap in large myelomeningocele closure. Neurosurg Focus. 2019 Oct 1;47(4):E19. doi: 10.3171/2019.7.FOCUS19383.
PubMed 31574473Kesan K, Kothari P, Gupta R, Gupta A, Karkera P, Ranjan R, Mutkhedkar K, Sandlas G. Closure of large meningomyelocele wound defects with subcutaneous based pedicle flap with bilateral V-Y advancement: our experience and review of literature. Eur J Pediatr Surg. 2015 Apr;25(2):189-94. doi: 10.1055/s-0034-1368796. Epub 2014 Mar 28.
PubMed 24683103
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Style Pedicled Perforators Propellers Flaps for Meningomylocele Defects Reconstruction With Sequential Advance in Perforators Dissection
- ClinicalTrials.gov ID
- NCT05188300
- Acronym / sponsor ID
- propellers flap
- Conditions
- Meningocele, Meningomyelocele
- Keywords
- Reconstructive Surgical Procedures / adverse effects, Meningomyelocele / surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 12 Jan 2022 (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.
To evaluate reliability of free style propeller perforator flap for coverage MMC soft tissue defect follow a well-established step that overcome the usual problem of pedicled perforators propellers flaps.
Detailed description
Meningomyelocele is a serious congenital birth defect that not only affect mortality and morbidity of neonate but also a lifelong health problem.
The estimated incidence of spina bifida is 1-2 cases per 1000 population. Meningomylocele soft tissue defect reconstruction is considered a lifesaving procedure , the ideal coverage technique should be time limited , reliable and allow healing line to be away from repair of the dura . all of these criteria are available in the selection of free style propeller perforator flap as a method of reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dorsal intercostal artery (DICA) perforator flaps | Experimental | Procedure: Freestyle pedicled perforators propellers flaps for meningomyelocele defectsRetrograde dissection of free style perforator arising from DICA according to region of dorsal spine and identification of paraspinal muscle where perforator vessel was found |
| Trapezius musculocutaneous perforator flaps | Experimental | Procedure: Freestyle pedicled perforators propellers flaps for meningomyelocele defectsRetrograde dissection of a free style perforator arising as a trapezius myocutenous perforator where the trapezius muscle is identified and a perforator vessel was isolated. |
| Lumbar artery perforators flaps | Experimental | Procedure: Freestyle pedicled perforators propellers flaps for meningomyelocele defectsRetrograde dissection of free style perforator arising from lumbar artery according to region of lumbar spine and identification of lumbar fascia where perforator vessel was found |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All cases with dorsolumbar meningomyelocele and age up to 6 months
Key exclusion criteria (3 listed)
- Infants older than 6 months
- concomitant congenital anomalies
- concomitant spinal kyphosis
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 |
|---|---|---|
| Freestyle pedicled perforators propellers flaps for meningomyelocele defectsFreestyle pedicled perforators propellers flaps for meningomyelocele defects reconstruction with sequential advance in perforators dissection, large number cases, and detailed successful technique. | Procedure or surgery | Dorsal intercostal artery (DICA) perforator flaps, Lumbar artery perforators flaps, Trapezius musculocutaneous perforator flaps |
Primary outcome
Feasibility of reconstruction technique
Time frame: Time of procedure
Measure the average operative time in minutes in each arm.
Pedicle dissection beyond the muscle
Time frame: Time of procedure
Compare the number of pedicle dissection beyond the muscle in each group.
1 secondary outcome
Meningomyelocele Repair Dehiscence and/or CSF leak
Time frame: Time of procedure
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 12 Jan 2022.
- Background: PubMed 34024069Kushida-Contreras BH, Gaxiola-Garcia MA. Myelomeningocele defect reconstruction with keystone flaps: vascular rationale for the design and operative technique. Arch Plast Surg. 2021 May;48(3):254-260. doi: 10.5999/aps.2020.01746. Epub 2021 May 15.
- Background: PubMed 31574473Formentin C, de Andrade EJ, Matias LG, Joaquim AF, Tedeschi H, Raposo-Amaral CE, Ghizoni E. Using the keystone design perforator island flap in large myelomeningocele closure. Neurosurg Focus. 2019 Oct 1;47(4):E19. doi: 10.3171/2019.7.FOCUS19383.
- Background: PubMed 24683103Kesan K, Kothari P, Gupta R, Gupta A, Karkera P, Ranjan R, Mutkhedkar K, Sandlas G. Closure of large meningomyelocele wound defects with subcutaneous based pedicle flap with bilateral V-Y advancement: our experience and review of literature. Eur J Pediatr Surg. 2015 Apr;25(2):189-94. doi: 10.1055/s-0034-1368796. Epub 2014 Mar 28.
- 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.
Mohamed K Kamel principal investigator
Assiut University
Awni M Shawkat, MD study chair
Assiut University
Mahmoud A Mohamed study director
Assiut 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 Freestyle pedicled perforators propellers flaps for meningomyelocele defects in people with Meningocele and Meningomyelocele, run by Assiut 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 1 inclusion and 3 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 12 Jan 2022. 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?
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?
Feasibility of reconstruction technique (time frame: Time of procedure). The study lists 2 primary outcomes in all. 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 NCT05188300, which also lists 3 linked publications.
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 12 Jan 2022; AzTrials last refreshed its copy on 30 Oct 2026.