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CSF LeakCSFNCT07368348

Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks

A study testing Internal Nasal Splint-Supported Free Graft and Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks in people with CSF Leak, run by Kafrelsheikh University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study aims to compare the feasibility and effectiveness of using an internal nasal splint- supported free graft versus a nasoseptal flap alone for endoscopic repair of bilateral CSF leaks. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
CSF Leak
What is being tested?
Internal Nasal Splint-Supported Free Graft and Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
1 Feb 2026to 1 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: 1- Adults (≥18 years). 2- Patients with bilateral CSF leaks confirmed by imaging and biochemical testing (e.g., beta-2 transferrin).

3- Patients with bilateral CSF leak and sever septal spur. 4- Patients with bilateral CSF leak and history of submucosal resection of nasal septum.

5- Patients with bilateral CSF leak and large septal perforation. 6- Patients with bilateral CSF Leak and septal granuloma.

Exclusion Criteria: 1- Patients with contraindications to endoscopic surgery. 2- Active sinus or nasal infections. 3- Previous nasal or skull base surgery affecting the repair site.

-

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amr Maher Shady, resident contact

0473109517

amrshady00@gmail.com

Egypt1 site, 1 recruiting
  • Kafrelsheikh Faculty of Medicine

    Kafr Elsheikh, Kafrelsheikh, 33155.

    Amr Maher Shady, resident, 0473109517, amrshady00@gmail.com

    Saad Elzayat Kafr Elsheikh Hospital University, professor, saad_hilmy@med.kfs.edu.eg

    Recruiting

Other trials in Egypt

About this study

The study aims to compare the feasibility and effectiveness of using an internal nasal splint- supported free graft versus a nasoseptal flap alone for endoscopic repair of bilateral CSF leaks.

Research question:

Does the use of an internal nasal splint to support a free graft during endoscopic repair of bilateral CSF leaks improve outcomes compared to the use of a nasoseptal flap alone?

Read the detailed description

Cerebrospinal fluid (CSF) leaks are classified as traumatic, iatrogenic, or spontaneous/idiopathic. Traumatic causes include blunt or penetrating facial injuries, while iatrogenic causes stem from neurosurgical or otolaryngologic procedures, such as Functional Endoscopic Sinus Surgery (FESS).

Spontaneous CSF leaks, often linked to elevated intracranial pressure (ICP), may occur in conditions like Idiopathic Intracranial Hypertension (IIH) or due to congenital skull base defects and tumors [2]. Risk factors for spontaneous leaks include obesity, female gender, and obstructive sleep apnea, with studies showing 72% of affected patients are female and 45% have sleep apnea.

Benign Intracranial Hypertension (BIH), also known as IIH or Pseudotumor Cerebri (PTC), involves increased brain pressure without structural abnormalities and normal CSF content. Spontaneous CSF rhinorrhea, increasingly prevalent (14-55%), often requires thorough investigations (e.g., fundus examination, CT/MRI, neurological consultation) to exclude intracranial hypertension before endoscopic repair.

Lumbar drain with CSF manometry is reserved for recurrent cases, often due to benign CSF tension increases despite normal preoperative findings. Successful repair requires competent flaps/grafts to withstand CSF pressure during healing. Recurrence necessitates further investigations and may require additional CSF diversion or shunting.

Key steps for successful repair include:

  1. Identifying the defect(s).
  2. Creating a raw area around the defect by removing mucosa.
  3. Precisely placing a graft or flap, optionally sealing dural tears with fat or fascia.
  4. Applying adequate pressure to counteract CSF pressure.

Sealing mechanisms involve:

  1. Tucking a graft or fat under bony edges or into dural tears, though this may risk dural trauma.
  2. Applying a free graft or vascularized flap over the defect and surrounding bone, requiring pressure equal to or greater than CSF pressure. Combining both mechanisms with adequate pressure optimizes sealing and compensates for potential weaknesses.

From a physical perspective, grafts or flaps must exert force equal to or greater than CSF pressure to prevent leaks. On-lay grafts require sufficient force, while under-lay grafts, though challenging, benefit from additional on-lay grafts or flaps to address unnoticed defects.

Nasoseptal flaps (NSFs) have become a widely used technique for endoscopic skull base repair, particularly for cerebrospinal fluid (CSF) leaks. They are vascularized pedicled flaps that provide a robust and reliable option for sealing skull base defects. Studies have shown that NSFs have high success rates, ranging from 90% to 95%, in preventing CSF leaks postoperatively. The vascularity of the flap promotes healing and reduces the risk of graft failure, making it a preferred choice for large or complex defect.

However, NSFs are not without limitations. The technique requires a relatively intact nasal septum, which may not be feasible in patients with prior septal surgery, large septal perforations, or severe septal deformities. Additionally, harvesting the flap can lead to complications such as nasal crusting, septal perforation, and nasal obstruction, which can affect patient quality of life.

Free grafts, such as fascia lata, fat, or synthetic dural substitutes, are another option for skull base repair. These grafts are non-vascularized and rely on the surrounding tissue for nourishment. Free grafts are simpler to harvest and place, making them a viable option in cases where NSFs are not feasible. However, their success rates are generally lower than those of NSFs, with reported success rates ranging from 70% to 85%.

The main challenge with free grafts is their susceptibility to displacement and failure due to the pressure exerted by CSF. Without adequate support, free grafts may not adhere properly to the defect, leading to recurrent leaks. Techniques to improve the stability of free grafts, such as the use of fibrin glue or additional support materials, have been explored, but these methods have not consistently improved outcomes.

The study aims to evaluate the effectiveness of internal nasal splints in improving the feasibility and success rate of free grafts during endoscopic CSF leak repair.

Conditions
CSF Leak
Being tested
Internal Nasal Splint-Supported Free Graft, Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
Keywords
CSF, Stent
Medical subject headings
Cerebrospinal Fluid Otorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internal Nasal Splint-Supported Free GraftDevice

    Evaluation of Internal Nasal Splint-Supported Free Graft versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks

  • Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid LeaksDevice

    Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks

Study groups in NCT07368348
Study groupRoleWhat they receive
Nasoseptal Flap for Endoscopic SkullExperimental• Group A: Free graft + Internal nasal splint * Free graft material (e.g., fascia lata, fat, synthetic dural substitute) placed over the defect. * Internal nasal splint applied to support the graft and maintain its position
Receives: Device: Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
Evaluation of Internal Nasal Splint-Supported Free Graft in Endoscopic SkulExperimental• Group B: Nasoseptal flap alone. - Standard nasoseptal flap technique used for skull base repair.
Receives: Device: Internal Nasal Splint-Supported Free Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of Internal Nasal Splint-Supported Free Graft versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks

    • Primary Objective:
    • To evaluate the effectiveness of internal nasal splints in improving the feasibility and success rate of free grafts during endoscopic repair of bilateral CSF leaks.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start1 Feb 2026
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07368348
Sponsor's protocol ID
KFSIRB200-695
Acronym
CSF
Status last verified
Sep 2025
First submitted
25 Dec 2025
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: anyone who is interestd in this study.

Publications

  • 1- Zhang S.N., Jiang Y., Yu L.G., Zhao L.J., Li L.L., Zhang C.Y., Xu W.R., Li N. (2019). Clinical analysis of transnasal endoscopic repair of cerebrospinal fluid rhinorrhea. Lin. Chung Er. Bi Yan Hou Tou Jing Wai Ke Za Zhi, 33(12): 1189-95. doi: 10.13201/j.issn.1001-1781.2019.12.018. 2- Kim-Orden N., Shen J., Or M., Hur K., Zada G., Wrobel B. (2019). Endoscopic endonasal repair of spontaneous cerebrospinal fluid leaks using multilayer composite graft and vascularized pedicled nasoseptal flap technique. Allergy Rhinol (Providence), 10: 2152656719888622. doi: 10.1177/2152656719888622.

Questions about this trial

What is this clinical trial studying?

A study testing Internal Nasal Splint-Supported Free Graft and Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks in people with CSF Leak, run by Kafrelsheikh 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?

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: looking for participants now, as of the sponsor's last update on 27 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amr Maher Shady, resident (0473109517, amrshady00@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Internal Nasal Splint-Supported Free Graft versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks (time frame: baseline). 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 NCT07368348, 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 27 May 2026.

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