Wounds and Injuries

All Conditions

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Nervous System Diseases

Rare Diseases

Syndrome

Congenital Abnormalities

Cerebrospinal Fluid Leak

Spinal Dysraphism

Neural Tube Defects

Spina Bifida Occulta

Nervous System Malformations

Tethered Cord Syndrome

Split Spinal Cord Malformation

Lipomyelomeningocele

Spina Bifida

Natriuretic Agents

Anticonvulsants

All Drugs and Chemicals

Acetazolamide

Carbonic Anhydrase Inhibitors

Enzyme Inhibitors

Diuretics

administration of Acetazolamide for 10 days following the surgery

Positioning the patient following surgery for 10 days

applying both Acetazolamide and prone positioning

Acetazolamide administration for 10 days adjust dosage with weight of the patient

prone positioning the patient for 10 days following the surgery

prone positioning

administration of acetazolamide and position the patient for 10 days following the surgery

Acetazolamide+ prone positioning

Farideh Nejat, MD

Shima Shahjouei, Student

* Purpose of study : to determine the preventive effect of acetazolamide administration, prone positioning, and the combination of both following the neurosurgical interventions in lumbosacral region for cerebrospinal fluid (CSF) leak, CSF collection and wound dehiscence.
* Sample size: 144
* intervention groups:

  * Group A: Acetazolamide administration for 10 days
  * Group B: prone positioning for 10 days
  * Group C: Acetazolamide administration and prone positioning for 10 days
  * Group D: no intervention
* Period of study: Autumn 2012 to the end of winter of 2015

The purpose of this study is to evaluate the effect of Acetazolamide administration and prone positioning following lumbosacral spinal surgery in preventing cerebro-spinal fluid leakage and collection and wound dehissence in children admitted to Children Medical Center of Tehran since Autumn 2012 to the end of winter of 2015.The study is run under 4 categories of intervention:

* Group A: Acetazolamide administration for 10 days
* Group B: prone positioning for 10 days
* Group C: Acetazolamide administration and prone positioning for 10 days
* Group D: no intervention All patients are randomly assigned to these groups and when the patients faced with any of these complications, the protocol changes to Acetazolamide administration and prone positioning and the patient is considered as the failure of the protocol.

Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence

Evaluating the Effect of Acetazolamide Administration and Prone Positioning Following Lumbosacral Spinal Surgery in Preventing Cerebro Spinal Fluid Leakage and Collection and Wound Dehiscence in Children.

leakage of CSF during 1 months following surgery

collection of the CSF beneath the skin during 1 month following the surgery

dehiscence of the surgical wound during the first month following surgery

Tehran University of Medical Sciences

Neoplasms

Meningitis

Cerebral Ventricle Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Coagulants

Thrombin

Hemostatics

Group of patients operated on for periventricular lesions with ventricular entry and placement of TachoSil directly over the area of ventricular opening in order to avoid complications.

Placement of TachoSil over the ventricular entry point in patients with periventricular lesions in order to avoid complications related to the ventricular entry.

TachoSil

Pilar Teixidor Rodriguez, MD, PhD

The working hypothesis in this study is that after entering the cerebral ventricular system the sealing with TachoSil is effective and safe.

A more specific hypothesis is that the use of Tachosil for brain surgery with ventricular entry reduces the number of postoperative complications (hydrocephalus, CSF leak, meningitis and pseudomeningocele).

Pilot observational study with medications (MOE), single-center, prospective and retrospective study with a group of patients operated on for periventricular lesions and with ventricular entry. As it is an infrequent type of surgery in our centre, the study includes a retrospective group (same surgery and use of TachoSil).

Primary objectives:

The main objective of the study is to evaluate the effectiveness and safety of TachoSil in patients who require ventricular entry.

To evaluate the effectiveness, the percentage of complications related to the ventricular entry during surgery are recorded. These complications are hydrocephalus, CSF leak, meningitis, and pseudomeningocele.

Secondary objectives

* Intraoperative incidence of fistula after application of the ventricular patch at 20cm PEEP H20 (efficacy objective).
* Incidence of clinically confirmed percutaneous fistula during the first 30 days after surgery (efficacy objective).
* Incidence of pseudomeningocele \>20cc confirmed with MRI or ultrasound (effectiveness objective).
* Incidence of radiologically confirmed hydrocephalus during the first 90 days after of the surgery.
* Record the percentage of use of other dural sealants
* Evaluate the cost effectiveness of the product.
* Describe the adverse effects related to the product
* Incidence of complication requiring reintervention within 30 days to the main surgery (safety objective).
* Assessment of the complications that are avoided: readmissions.

Study period: from December 2020 to December 2023.

Observational Pilot Study With TachoSil as a Ventricular Sealant

To evaluate the effectiveness and the percentage of complications related to the ventricular entry during surgery. Taking into account hydrocephalus, CSF leak, meningitis and pseudomeningocele.

Percentage of complications with percutaneous CSF leakage pseudomeningocele/ hydrocephalus/meningitis

Germans Trias i Pujol Hospital

Musculoskeletal Diseases

Hypertrophy

Skull Base Neoplasms

Pathological Conditions, Anatomical

Skull Neoplasms

Bone Neoplasms

Bone Diseases

Neurologic Manifestations

Craniocerebral Trauma

Trauma, Nervous System

Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site following endoscopic skull base surgery

Participant will have a silastic splint (Non-Absorbable Packing) applied to the nasoseptal flap harvest site following endoscopic skull base surgery with no additional packing or agent

Participant will have silastic splint applied to nasoseptal flap harvest site

Non-Absorbable Packing (Silastic Splint)

Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site

PuraGel (RADA16) Hydrogel

Satyan Sreenath, MD

The purpose of this study is to specifically evaluate the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in expediting post-operative healing and re-mucosalization of the nasoseptal flap harvest site during endoscopic skull base surgery and the impact on patient and sinonasal morbidity.

Briefly, multiple agents exist and have been long-studied in endoscopic sinus and septal surgery, which include non-absorbable agents and biodegradable, absorbable synthetic agents including extracellular matrix (ECM) based compounds and synthetic biopolymers. The goal of these agents has often been to reduce sinonasal crusting, postoperative bleeding, and synechia formation. With advancements in postoperative adjuncts, many options now exist for postoperative sinonasal packing including medicated products such as steroid-impregnated stents and chitosan-based absorbable packs.

Lastly, with respect to intra-operative adjuncts designed to foster healing in the postoperative period, PuraGel, a RADA16 polypeptide hydrogel, was identified as an ECM-based solution, which aids in wound healing, adhesion prevention, and hemostasis at the completion of the case. In hydrogel format, this agent forms a synthetic matrix that serves as a scaffold for mucosal healing while serving as a mechanical barrier on tissue surfaces, thereby limiting scarring. To date, there have been no studies evaluating the role of this gel-based compound in the postoperative period in endoscopic skull base surgery.

Thus, amongst all of these agents that have been previously studied to some degree in patients undergoing endoscopic sinus surgery, there has been limited study on their role in endoscopic skull base surgery and utility in reducing sinonasal morbidity in the postoperative setting. Therefore, our goal was to investigate and compare the impact of varying sinonasal agents in the nasal cavity following endoscopic skull base surgery. We hypothesize that the absorbable, ECM-based gel compound (PuraGel) demonstrates an improvement on postoperative healing rate and sinonasal crusting with reduced patient morbidity and improved patient comfort when compared to non-absorbable agents.

This will be double blinded (video endoscopy will be performed and scoring will be performed by non-operative surgeon, blinded to the intervention group).

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Novel Application of RADA16 Hydrogel in Reducing Sinonasal Morbidity After Endoscopic Skull Base Surgery

Modified Lund-Kennedy nasal endoscopy score to rate mucosal edema, nasal crusting, and scarring. This will be double blinded (video endoscopy will be performed and scoring will be performed by non-operative surgeon, blinded to the intervention group). This scoring will address wound healing, adhesion formations. Scoring will be performed at 1 week, 4 weeks, and 12 weeks following surgery. The timing of these assessments is based on the routine postoperative follow-up schedule. No additional appointments will be made for the purposes of this study. We will be looking at the change in this score over time.

Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Modified Lund-Kennedy nasal endoscopy score.

Patient-reported pain visual analog scale during postoperative debridement of the main nasal cavity. Minimum score is 1 (reflecting no pain) and the maximum score is 10 (reflecting extreme amount of pain).

Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Patient-reported pain visual analog scale.

Postoperative, subjective QOL score with the validated Anterior Skull Base Nasal Inventory-12 (ASK-12) at 1 week, 4 weeks, and 12 weeks postoperatively.

Minimum would be 0. Maximum would be 72. Higher score means worse outcome. The un-abbreviated title is Anterior Skull Base Nasal Inventory-12.

Likert scale of mucosalization of the nasal septum graded by blinded reviewer via nasal endoscopy video

Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Likert scale of mucosalization.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence	NCT01867268	Fibrolipoma of ... Lipomyelomening... Split Cord Malf... Dermal Sinus Tethered Cord S... Tumor	Acetazolamide prone positioni... Acetazolamide+ ...	- 18 Years	Tehran University of Medical Sciences
Observational Pilot Study With TachoSil as a Ventricular Sealant	NCT05717335	Intraventricula...	TachoSil	18 Years -	Germans Trias i Pujol Hospital
Observational Pilot Study With TachoSil as a Ventricular Sealant	NCT05717335	Intraventricula...	TachoSil	18 Years -	Germans Trias i Pujol Hospital
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery	NCT05898074	Skull Base Neop... Cerebrospinal F... Nasal; Hypertro...	Non-Absorbable ... PuraGel (RADA16...	18 Years -	Indiana University

Spots Global Cancer Trial Database for cerebrospinal fluid leakage