Surgical Sealants and Fat Grafts Quiz

Oxiplex® - Adhesion Barrier for Spine Surgery

• Oxiplex® is a safe, easy-to-use gel for spine surgery
• It reduces adhesions and associated symptoms like pain
• Oxiplex has been available since 2002 and has been extensively studied worldwide
• It's a mechanical barrier to adhesion formation
• It's absorbable, synthetic, and biocompatible
• Clear gel, does not obstruct the operative site, and permits normal wound healing
• Contains no animal or bacterial components

Spinal Adhesions

• Adhesions are the adherence of dura and/or nerve roots to surrounding structures
• Common types are epidural fibrosis, peridural fibrosis, and perineural fibrosis

Adhesions After Spine Surgery

• Chemical irritants cause pain, weakness, and adhesions
• Failed back surgery can result in leg pain, back pain, weakness, numbness, tingling, and burning
• During procedures like laminectomy, laminotomy, and discectomy, dura and nerve roots are often exposed
• Inflammatory mediators, cytokines, and fibroblasts migrate to the site, potentially causing pain and adhesions

Re-Operations

• Up to 40% of failed back surgeries (FBSS) require re-operation
• Re-operations can be complicated by adhesions at the original operative site
• Re-operations can lead to more adhesions

Oxiplex® Adhesion Barrier for Spine Surgery

• Clear gel in a 3mL sterile syringe with a flexible applicator tip
• Reorder number: FPC-09006
• The product is the leading adhesion barrier for spine surgery worldwide, with over 600,000 units sold globally.
• An excellent safety profile

Oxiplex® Gel

• A mechanical barrier to inflammatory mediators, cytokines, and fibroblasts, which may cause pain and adhesions
• Applied following decompression to nerve root, dural sac, and annulus fibrosus to the level of laminectomy

Gel Physical Characteristics

• Biocompatible and absorbable
• Synthetic, with no animal or bacterial components
• Viscous, tissue-adherent
• Does not swell
• Clear/colorless, allowing visualization of the operative site
• Room temperature storage with a 2-year shelf life

Storage and Handling

• Store between 2°C and 25°C
• Do not expose to temperatures between 26°C and 39°C for more than 6 days
• Never exceed 39°C

Packaging

• Sterile in a thermoform tray
• Includes a 3mL syringe (luer lock) and an applicator (luer lock)
• Instructions for use and patient tracking labels are also provided

Composition of Oxiplex® Gel

• Composed of two polymers: carboxymethylcellulose (CMC) and polyethylene oxide (PEO)
• CMC is a polysaccharide polymer of glucose, water-soluble, and viscous
• PEO is a water-soluble polymer that reduces fibrin deposition

Mode of Action

• Oxiplex® coats surfaces exposed in spinal decompression surgery to create a temporary physical barrier
• The barrier isolates exposed nerve fibers and dura from surrounding tissues
• This reduces peridural fibrosis and limits exposure of nerve tissue to irritants that may cause pain

Resorption Process & Rate

• Resorption occurs through hydrolysis and macrophage activity over 28-30 days
• Hydrolysis is the breaking of chemical bonds by adding water
• Biocompatible components mean no inflammatory response

MRI Scan with Oxiplex®

• Image of a spine with Oxiplex® applied, showing the 10-day postoperative condition

Instructions for Use

• Oxiplex® is a mechanical barrier to adhesion formation, specifically placed around neural tissues after spine surgery
• This aims to limit adhesion formation and associated symptoms like pain

Instructions for Use - Preparation

• Remove the thermoform from the carton. Note the exterior of the carton and tray are not sterile
• Peel open the tray to maintain sterility and place the syringe and applicator onto the sterile field
• Secure the applicator tip onto the syringe

Gel Application

• Oxiplex gel is applied intraoperatively during lumbar laminectomy, laminotomy, or discectomy
• It coats dura and exiting nerve root along all surfaces
• Gel fills the depth of the surgical site to the level of the ventral surface of the vertebral lamina
• Do not irrigate the surgical site after applying Oxiplex gel

Gel Application (Continued)

• Provides links to YouTube videos demonstrating Oxiplex application to nerve roots

Clinical Performance

• Excellent safety profile with over 600,000 spine surgery patients worldwide treated using Oxiplex
• No device-related adverse events reported in the US IDE study
• No clinically significant abnormal lab or physical findings
• Fewer neurological complications and re-operations
• No CSF leaks in Oxiplex® patients

Clinical Performance (Continued)

• Extensive pre-clinical testing shows Oxiplex reduces epidural fibrosis without affecting dural healing
• Oxiplex does not inhibit normal bone healing

U.S. Pivotal Clinical Trial Results

• Prospective, randomized, blinded, multi-center trial in 352 patients at 29 sites evaluating safety and effectiveness reducing pain after lumbar disc surgery
• Patients were randomized to receive either Oxiplex® with surgery or surgery alone
• Patients were assessed at baseline and at 1, 3, and 6 months post-operatively

Oxiplex® Gel Study Group

• A list of study physicians involved in Oxiplex® research and trials

Clinical Publications

• Research publication demonstrating Oxiplex® reduces leg pain, back pain, and associated symptoms after lumbar discectomy
• A prospective, randomized, blinded, clinical trial evaluating the efficacy of Oxiplex®

Consistent Clinical Benefit with Oxiplex®

• Across all measured attributes, Oxiplex® shows statistically significant improvement at 6 months compared to surgery-only control groups, measured in leg pain, back pain, leg weakness, physical symptoms, patient satisfaction, disability days, and daily living activities

Benefits of Oxiplex® vs. Surgery Alone

• Oxiplex® significantly reduced leg pain and back pain at 6 months in patients with severe baseline back pain
• P-values for these improvements are provided

Fewer Disability Days in Oxiplex® Subjects

• Oxiplex reduced disability days by 2.07 days (P = .0497) compared to surgery alone at 6 months
• Represents a 27% reduction in subjects.

Greater Satisfaction in Oxiplex® Subjects

• Statistically significant improvement in patient satisfaction at 6 months in patients taking Oxiplex, compared to surgery alone
• P-value of 0.0152 is provided

Fewer Re-Operations in Oxiplex® Group

• Six-fold fewer re-operations in patients treated with Oxiplex® compared to surgery-only patients at 6 months
• P-value not provided

Study Summary

• Fewer residual leg and back pain
• Fewer neurological symptoms
• No post-op CSF leaks
• Fewer re-operations
• Enhanced patient satisfaction
• Less disability days
• Improvement in daily activities

Oxiplex® Independent Studies

• List of independent studies that all confirm safety and efficacy of Oxiplex®
• Each study includes author, number of participants (# Pts.), study title and meeting

Peer-Reviewed Oxiplex® Publications

• List of peer-reviewed publications, author, number of participants (# Pts.), study title, and journal name
• Confirm safety and efficacy

Benefits

• Exceptional safety for spine surgery
• Designed, shown safety and performance in spine surgery, and ready for use
• Fast application, provides thorough coverage and colorless appearance, allowing for clear view of surgical field and neural elements
• Absorbs

Benefits (Continued)

• Procedure protection, separating and coating tissues, and a barrier to biochemical irritants
• Optimizes healing with moderate pain, fewer adhesions, and easier re-operations
• Improves outcomes, minimizing leg and back pain, and reducing re-operation rates

Why Use Oxiplex®

• Leading adhesion barrier worldwide (600,000 units distributed worldwide)
• Exceptional safety record
• Synthetic biomaterial, no animal by-products
• Effective; fewer adhesions, better outcomes, easier re-operations
• Easy use: no gel mixing or refrigeration needed
• Simple application

Competitors - Hyalobarrier®

• Aqueous gel of ACP200, a cross-linked ester of hyaluronic acid, that is a barrier to protect and separate tissues
• Easy manipulation
• Completely degrades within 7 days
• Water consistency; doesn't stay put
• Requires refrigeration

Competitors - Guardix

• Adhesion barrier as a viscous solution (gel)
• Comprised of hyaluronic acid and carboxymethylcellulose (CMC)
• Sterile, transparent, colorless
• Slowly resorbed within 14 days; excreted in less than 28 days
• Suitable for general, laparoscopic, gynecological, neurosurgical, spinal, ENT, and orthopedic surgeries

Competitors - DuraSeal Sealant System

• Mixture of two separate solutions: polyethylene glycol (PEG) ester solution and trilysine amine solution
• Used as an adjunct to sutured dural repair in cranial surgeries to provide watertight closure
• Complicated to assemble and use, mist and hydrogel need pre-mixing, and swelling up to 50%

Competitors - Fat Grafts

• Autologous pedicle or subcutaneous fat grafts
• Grafts shrink but are not usually absorbed
• No clinical benefit for adhesion prevention
• Complications include necrosis, excessive fibrosis, preventing bone healing, and compression of the spinal cord

Test your knowledge on surgical sealants and fat grafts with this quiz. Explore the components of Guardix SOL, the DuraSeal Sealant System, and the clinical benefits and complications associated with fat grafting. Perfect for surgical students and professionals alike!