Surgical Sealants and Fat Grafts Quiz

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Questions and Answers

Which component is NOT a part of the formulation for Guardix SOL?

Carboxymethyl Cellulose

Hyaluronic Acid

Sterile solution

Polyethylene glycol (correct)

What is a disadvantage of the DuraSeal Sealant System?

Excreted from the body in less than 28 days

Requires pre-mixing before use (correct)

Slowly resorbed within 14 days

Indicated for spinal surgery

What is the primary clinical benefit associated with fat grafts?

Adhesion prevention

Minimizing postoperative complications

Providing autologous tissue (correct)

Watertight closure during cranial surgery

In which type of surgery is Guardix SOL specifically indicated?

Gynaecological surgery Signup and view all the answers

Which of the following is NOT a complication associated with fat grafts?

Swelling up to 50% Signup and view all the answers

What is the primary benefit of using Oxiplex in spine surgery?

It improves outcomes by reducing adhesions and pain Signup and view all the answers

Which of the following is commonly referred to as epidural fibrosis?

Adherence of dura and/or nerve roots to surrounding structures Signup and view all the answers

What percentage of patients undergoing spine surgery are estimated to require re-operation due to failed back surgery?

20% Signup and view all the answers

What is the primary mechanism by which Oxiplex functions during spine surgery?

It acts as a mechanical barrier to pro-inflammatory mediators Signup and view all the answers

Which statement about Oxiplex Gel is true?

It has a clear gel consistency and comes in a 3mL sterile syringe Signup and view all the answers

Which potential symptom may result from spinal adhesions after surgery?

Reduced flexibility in the spine Signup and view all the answers

What has been a significant concern related to re-operations after spine surgery?

Increased potential for new adhesions Signup and view all the answers

Which of the following describes a characteristic of Oxiplex Gel?

It possesses an excellent safety profile Signup and view all the answers

What is the primary purpose of Oxiplex® Gel in spinal decompression surgery?

To coat surfaces and form a physical barrier. Signup and view all the answers

Which of the following is NOT a characteristic of Oxiplex® Gel?

Composed of natural animal components. Signup and view all the answers

What should be avoided when storing Oxiplex® Gel?

Exposure to temperatures above 39 °C. Signup and view all the answers

What process is responsible for the resorption of Oxiplex® Gel?

Hydrolysis and macrophagic activity. Signup and view all the answers

Which component of Oxiplex® Gel reduces the deposition of fibrin?

Polyethylene oxide (PEO). Signup and view all the answers

What was the percentage of re-operations in the Oxiplex group after six months?

0.6% Signup and view all the answers

What is the shelf life of Oxiplex® Gel when stored appropriately?

2 years. Signup and view all the answers

Which characteristic of Oxiplex® Gel allows visualization of the operative site?

Its clear and colorless appearance. Signup and view all the answers

Which of the following is NOT mentioned as a benefit of using Oxiplex?

Requires refrigeration for storage Signup and view all the answers

What is primarily used for the stabilization of Oxiplex® Gel in its aqueous solution?

Calcium chloride and sodium chloride. Signup and view all the answers

How does Oxiplex optimize healing in patients undergoing spine surgery?

By minimizing irritation from biochemical agents Signup and view all the answers

What characteristic of Oxiplex aids visibility during surgery?

It is colorless. Signup and view all the answers

What is the primary purpose of Oxiplex® in spine surgery?

To reduce adhesion formation Signup and view all the answers

How many units of Oxiplex have been distributed worldwide?

600,000 Signup and view all the answers

When should Oxiplex® be applied during surgery?

At the end of surgery after hemostasis Signup and view all the answers

What sets Oxiplex apart from its competitor Hyalobarrier?

It is a synthetic biomaterial with no animal by-products. Signup and view all the answers

Which of the following surfaces should Oxiplex® be applied to?

All exposed surfaces including dorsal, ventral, medial, and lateral Signup and view all the answers

What is a potential disadvantage of Hyalobarrier compared to Oxiplex?

Requires refrigeration for storage. Signup and view all the answers

What should not be done after applying Oxiplex®?

Irrigate the surgical site Signup and view all the answers

What was the primary objective of the clinical trial evaluating Oxiplex gel?

To evaluate the effectiveness of Oxiplex gel for reducing pain after lumbar discectomy. Signup and view all the answers

Which parameter showed significant improvement due to Oxiplex treatment at 6 months?

Reduction in leg and back pain. Signup and view all the answers

What evidence supports the safety and efficacy of Oxiplex®?

Ten additional studies demonstrating safety and efficacy Signup and view all the answers

Which effect of Oxiplex contributes to enhanced patient satisfaction?

Lower re-operation rates Signup and view all the answers

What was a notable finding regarding disability days in the trial?

Oxiplex significantly reduced disability days compared to surgery alone. Signup and view all the answers

How many spine surgery patients have been treated with Oxiplex® worldwide?

Over 600,000 Signup and view all the answers

What notable result was observed in the U.S. IDE study regarding neurological complications?

Fewer neurological complications in the Oxiplex® group Signup and view all the answers

Which group experienced a higher level of patient satisfaction at 6 months?

Oxiplex-treated subjects with severe baseline back pain. Signup and view all the answers

What does the conclusion of the study suggest about Oxiplex gel?

It improves clinical outcomes in discectomy procedures. Signup and view all the answers

Which of the following is a characteristic of Oxiplex® based on clinical performance studies?

Reduces epidural fibrosis without affecting dural healing Signup and view all the answers

Which clinical outcome was NOT measured in the trial?

Cost of treatment. Signup and view all the answers

In which aspect did the Oxiplex-treated group demonstrate superior results compared to the surgery-alone group?

Improvement in physical symptoms. Signup and view all the answers

What treatment did the subjects in the control group receive?

Surgery alone. Signup and view all the answers

Study Notes

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

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Description

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!