Clinical Trials About "Australia Dura Substitute Procedures Outlook 2025 Report Updated" RSS

02:45 EST 21st November 2019 | BioPortfolio

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Showing "Australia Dura Substitute Procedures Outlook 2025 Report Updated" Clinical Trials 1–25 of 7,100+

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Study of SyntheCelTM Dura Replacement to Other Dura Replacements

Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the cranial dura.

SyntheCel Dura Replacement in Patients Requiring Dura Repair

The objective of the clinical investigation is to demonstrate that the SyntheCelTM Dura Replacement is substantially equivalent to other dura replacements cleared for marketing by the FDA in terms of safety (incidence of surgical site infections) and effectiveness (absence from CSF leaks) for the treatment of dural repair following cranial surgery.

Fibrin Sealant for the Sealing of Dura Sutures

The purpose of this study is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa surgery as an adjunct to dura and dura substitute sutures in preventing postoperative cerebrospinal fluid (CSF) leakage.

A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.

The objective of this study is to evaluate the safety and effectiveness of ArtiFascia® in comparison with commercially available dural substitutes in patients requiring Dural repair following neurosurgery. Patients with planned cranial neurosurgery can take part in this study. During the surgery the soft membrane that covers the brain (called dura) is likely to be cut and damaged. A damaged dura can cause a leakage of brain fluids (cerebrospinal fluid [CSF] leakage) and ...


Post-market Assessment of Biodesign Dural Repair Grafts

The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.

Outlook: An Intervention to Improve Quality of Life in Serious Illness

This study will demonstrate whether an end-of-life preparation and completion intervention reduces anxiety, depression, pain and other symptoms and improves functional status, spiritual well-being, and quality of life. If effective, the intervention offers a brief, inexpensive, and transportable non-physician treatment method for improving the experience of individuals in the latter stages of life-limiting illness.

The Effect of Patient Optimism & Pessimism on Recovery From Elective Cardiac Surgery

Before a heart operation, patient outlook may be either pessimistic or optimistic. Previous research on this topic has focused on patient reported quality of life but has never examined measurable clinical outcomes such as length of hospital stay.This pilot study hopes to establish whether patient outlook (optimistic or pessimistic) before a heart operation can influence recovery and length of hospital stay. If there is a difference, then a case can be made for providing psycho...

Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.

The Effects of CGMP in Children and Adults With PKU

Randomised controlled trial with a crossover design. For early and continuously treated patients with phenylketonuria (PKU) that are adherent. Two 12-week periods where patients consume either casein glycomacropeptide (CGMP) based protein substitute or a free amino acid (AA) based protein substitute. 4 week wash out period in between. The protein substitutes will be consumed daily together with the patient's regular low protein diet.

Effect of Dural Release on Women With Back and Neck Pain After Obstetrics and Gynecological Surgery

Something must be done in order to release the tension within the dura mater before any lasting correction of the spine can be effected. Each of the cranial nerves is wrapped in a sheath of dura mater. As they exit the cranial vault they are described by Gray's Anatomy as having a "dural cuff".

A 16 Week Study Evaluating the Introduction of a GMP Based Protein Substitute in Participants With PKU

This study aims to measure changes in participants' blood phenylalanine (Phe) levels in participants with PKU when switching from a conventional amino acid based protein substitute to a GMP based protein substitute (PKU Sphere) over a 16 week period.

Hemopatch Performance Evaluation: A Prospective Observational Registry

To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.

Feeding Patterns and Practices in Young Children With PKU During the First Two Years of Life

In this study the feeding patterns and practices at the introduction of a second stage phe-free protein substitute will be assessed in young children with PKU. This will be compared with the normal weaning process in healthy non-PKU age-matched children. In addition, tolerability and acceptability of the study product will be evaluated in a smaller group of subjects who have already been transferred onto a second stage protein substitute. The study is performed in 3 centers in ...

Evaluation of Efficacy and Safety of Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation

Evaluation of efficacy and safety of Wishbone HA as bone graft substitute, a pre-market clinical investigation. Group1: Extraction Socket management Group 2: Sinus lift

Clinical and Radiographic Evaluation of PPF With or Without NCHA Bone in Treatment of Intrabony Defects

This study is meant to assess clinically and radiographically the possible predictable results regarding the use of nanocrystalline hydroxyapatite bone graft substitute together with papilla preservation flap versus papilla preservation flap alone in the treatment of periodontal intrabony defects. Patients will be randomly assigned to either test or control group. The two groups will be equally prepared for both surgical procedures. Then the decision of which group will receive...

EMD and/or Bone Substitute for the Treatment of Class II Furcations

To clinically evaluate the treatment of mandibular class II furcation defects with enamel matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium phosphate/hydroxyapatite (βTCP/HA).

Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial

Despite all prevention efforts, many people in Australia continue to be infected with HIV. The Seventh National HIV Strategy 2014-2017 in Australia aims to work towards the elimination of HIV transmission by the year 2020. This project will evaluate a new additional way to lower people's chances of getting HIV. It will provide pre-exposure prophylaxis (PrEP) to people who are at high risk for HIV and evaluate what impact this new prevention approach will have on HIV in WA at th...

Assessment of HydroxyColl Bone Graft Substitute in High Tibial Osteotomy Wedge Grafting.

The overall goal of this study is to demonstrate the safety and efficacy of Hydroxycoll bone graft substitute when used in the treatment of patients undergoing surgical treatment for varus mis-alignment in medial unicompartmental osteoarthritis of the knee. HydroxyColl bone graft substitute will be evaluated when utilized in Open Wedge High Tibial Osteotomy with medial plate fixation. Its safety profile will be evaluated as defined by the number of reported adverse events.

Performance and Safety of Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures

The purpose of this study is to evaluate the performance and to monitor the safety of the bone substitute Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) in Sinus Lift Procedures . This study will be conducted in two parts: part A evaluates safety and performance of MBCP-FS in bone regeneration i.e. the amount of new bone that is formed and its suitability for dental implant placement. Part B is designed to...

Non-missile Penetrating Head Trauma,Cases Registry in Sohag University Hospital

A retrospective study was done in Neurosurgery trauma unit, Sohag University. Eighteen patients reported with different mechanisms of trauma. All patients clinically tested involving neurological evaluation. Computed tomography brain was done for them at the time of admission. Cautious removal of the penetrating object with local debridement of surrounding tissues including skin, skull, dura and brain tissue and watertight closure of the dura should be done. Patients transferre...

An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia

This study is designed to estimate the effectiveness of nivolumab when given to participants after removing their cancer with surgery, over a 5-year follow-up, in real-world conditions in Australia.

Prospective, Comparitive, Randomized Study of Allograft Versus Skin Substitute in Non-healing Diabetic Foot Ulcers

The purpose of this study is to determine whether amnion membrane grafts are more effective than another tissue engineered skin substitute, when used to treat diabetic foot ulcers (DFUs).

Clinical Evaluation of PoreSkin

PoreSkin, a human acellular dermal matrix (hADM) manufactured by Faculty of Medicine, Chulalongkorn University, is the first human dermal substitute developed in Thailand. It is a permanent dermal substitute aiming to reduce skin contracture. The objective of this study is to assess the safety and ability in achieving durable and cosmetic coverage of PoreSkin.

China Salt Substitute Study

Cardiovascular disease is a leading cause of death and disability worldwide, and blood pressure is a leading determinant of this risk. To date, strategies for blood pressure lowering have focused on drug treatment but dietary interventions such as reducing sodium intake and increasing potassium intake may also be effective. Such interventions may be particularly suitable for low- and middle-income countries in which significant dietary changes may be more easily achieved. Th...

Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions

This is a prospective observational study, consisting of 3 substudies carried out during elective neurosurgery under general anaesthesia. Each participant will take part in all 3 substudies. First, the capability of Near Infra Red Spectroscopy (NIRS) to measure the brain oxygenation is examined. A NIRS-electrode is placed on forehead skin, on the skull, and on dura. Secondly, a small dose of Phenylephrine is given, and the brain oxygenation is measured by a Clark-electrode and ...

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