Phase 3 N=34 Duragen Versus Duraguard in Chiari Surgery
Chiari Malformation
Primary: Physical Health Quality of Life — 31.4; 35.61 units on a scale
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=92 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.
Dural Tear · Cerebrospinal Fluid Leak
Primary: Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging. — 0; 0; 27; 58…
N/A N=105 Study of SyntheCelTM Dura Replacement to Other Dura Replacements
Cranial Dura Repair
Primary: Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele — 57; 33 participants
N/A N=237 DuraSeal Sealant Post Market Study
Elective Cranial Procedures With Dural Incision
Primary: Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to…
Phase 3 N=726 TASALL - TachoSil® Against Liquor Leak
Cerebrospinal Fluid Leaks
Primary: Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure — 6.9…
Phase 3 N=224 Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery
Cerebrospinal Fluid Leak
Primary: Number of Participants With No CSF Leak During and After Surgery — 76; 87 Participants
N/A N=240 Glove Perforation When Using Blunt Verses Sharp Needles in Cesarean Delivery
Cesarean Delivery · Glove Perforation
Primary: Surgical Glove Perforation. — 30; 30 Cases with a glove puncture
Phase 3 N=250 Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
Elective Cranial Procedures With Dural Incision
Primary: Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak /…
N/A N=19 MRI Diffusion Tensor Tractography to Monitor Peripheral Nerve Recovery After Severe Crush or Cut/Repair Nerve Injury
Nerve Injury
Primary: Michigan Hand Questionnaire (MHQ) in TPNI Subjects Post Surgery — 33; 83; 5; 75 score on a scale
N/A N=140 Dural Puncture Epidural Versus Epidural Anesthesia for Cesarean Delivery
Pain Levels
Primary: Onset Time of Surgical Anesthesia — 422; 655 seconds
Phase 3 N=234 The EVICEL® Neurosurgery Phase III Study
Cerebrospinal Fluid Leak
Primary: Primary Effectiveness Endpoint Success Number of Successes (Subjects That Had no Inter-operative CSF Leak Following Valsalva Maneuver and no CSF Leak or…
N/A N=260 Comparison of Two Spinal Needles Regarding Postdural Puncture Headache
Anesthesia; Adverse Effect, Spinal and Epidural, Headache · Complications; Anesthesia, Spinal and Epidural, in Pregnancy
Primary: Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section — 14; 10 participants
Phase 2 N=75 Fibrin Sealant for the Sealing of Dura Sutures
Pathological Processes in the Posterior Fossa · Dura Defects
Primary: Incidence of Cerebrospinal Fluid (CSF) Leakage Observed After Surgery — 74.07; 78.13 percentage of participants — p=0.7159
N/A N=98 Study to Evaluate Safety & Effectiveness of Spinal Sealant
Cerebrospinal Fluid Leakage, Subdural
Primary: Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) — 98.0; 79.2 percentage of participants
N/A N=162 Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Arnold-Chiari Malformation, Type 1 · Chiari Malformation Type I · Type I Arnold-Chiari Malformation
Primary: The Number of Participants With Surgical Complications — 8; 10 Participants
N/A N=500 Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
Head Trauma · Craniocerebral Injuries · Crushing Skull Injury
Primary: Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level — 85.6 percentage
N/A N=282 Single or Double-layer Uterine Closure Techniques
Uterine Scar · Cesarean Section Complications · Cesarean Section; Dehiscence
Primary: Number of Participants With Niche Visualized by Saline Infusion Sonography — 40; 53; 25; 23 Participants — p=0.05
N/A N=158 Study to Evaluate Safety and Effectiveness of Spinal Sealant
Spinal Procedure Requiring Dura Incision
Primary: Watertight Dural Closure — 102; 36 Participants
Phase 4 N=107 Decreasing Intraoperative Skin Damage in Prone Position Surgeries
Pressure Injury
Primary: Number of Participants With Intraoperative Acquired Pressure Injuries (IAPI) — 13; 14 Participants
N/A N=30 Study of Suture Repair of Torn Meniscus in the Knee
Meniscal Tear · Meniscus Tear
Primary: Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation) — 26; 1; 23; 2 Participants
N/A N=96 Scalpel vs Diathermy in Repeat Cesarean Delivery
Complications; Cesarean Section
Primary: Incision Time . — 271.5; 188.17 Seconds — p=<0.001
N/A N=376 Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
Chronic Subdural Hematoma
Primary: Residual or Re-accumulation of the Chronic Subdural Hematoma (cSDH) (Greater Than [>] 10 Millimeter [mm]) as Assessed by an Independent Core Laboratory OR Any…
Phase 4 N=97 A Comparison of Polyglactin 910 and Chromic Gut Suture in the Closure of Punch Biopsy Sites
Wound Closure Technique
Primary: Presence of Scarring — 1; 1 participants
N/A N=151 A Skin Glue Versus Subcuticular Suture for Cesarean Closure Study
Cesarean Section · Complication · Wound
Primary: Patient Scar Satisfaction Scale Score — 13; 13.5 score on a scale
Phase 4 N=141 DPE Technique in Labor Epidural for Morbidly Obese Women
Morbid Obesity · Labor Pain
Primary: Number of Participants Who Required Asymmetric Block, Top-up Interventions, Catheter Adjustments, Replacement of Epidural Catheter, or Failure of Block Requiring…
N/A N=672 Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
Head Trauma · Craniocerebral Injuries · Crushing Skull Injury
Primary: Number of Participants With Detection of Hematoma Stratified by CT Positive and CT Negative Status — 158; 22; 126; 81 Participants
N/A N=63 Incidence of Headache Following an Unintentional Dural Puncture
Postdural Puncture Headache · Post-Lumbar Puncture Headache · Cerebrospinal Fluid Leaks
Primary: Participants Who Report Post Dural Puncture Headaches — 21; 27 Participants — p=.877
N/A N=38 Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Colorectal Cancer
Primary: Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. — 4 Participants
N/A N=6 An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures
Brow Ptosis · Surgical Wound
Primary: Scar Appearance — 7; 2.33 score on a scale
N/A N=132 The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain
Labor; Prolonged, Second Stage · Episiotomy Wound
Primary: Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score — 1; 1; 0 REEDA Score