Practitioners

Chitogel is a highly effective postoperative hydrogel nasal dressing that can be applied to sinuses after endoscopic sinus surgery and addresses a number of the traditional sinus surgery shortcomings1 1Ha T, Valentine R, Moratti S, Hanton L, Robinson S, Wormald PJ. The efficacy of a novel budesonide chitosan gel on wound healing following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2018 Mar;8(3):435-443.:

  • Reduces frontal, sphenoid & maxillary ostial stenosis following endoscopic sinus surgery
  • Reduces adhesion formation
  • A soft, pliable and easily applied dressing that is supportive and stenting optimizing patient comfort
  • A Haemostatic agent, controls minimal bleeding following surgery by the tamponade effect, blood absorption and platelet aggregation
  • Clears naturally post surgery with nasal irrigation

  • A proven adjunct to aid in the natural wound healing process
    • Reduces granulation tissue formation
    • Reduces edema
    • Reduces pus formation
    • Reduces incidence of crust formation

Clinically Proven Results

Clinical results show that where Chitogel has been used post surgery, compared to using no packing materials at 12 months post surgery, patients on average experienced the following:1 1Ha T, Valentine R, Moratti S, Hanton L, Robinson S, Wormald PJ. The efficacy of a novel budesonide chitosan gel on wound healing following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2018 Mar;8(3):435-443.

73%

Improvement in frontal ostial area

Read more

35%

Improvement in sphenoid ostial area

Read more

34%

Improvement in maxillary ostial area

Read more

47%

Reduction in incidence of adhesion

Read more

50%

Reduction in incidence of edema

Read more

50%

Reduction in incidence of granulation

Read more

Chitogel: The Natural Choice for Postoperative Care.

Chitogel ESS Kit Contents

The Chitogel Endoscopic Sinus Surgery Kit (the “Kit”) contains components and equipment for the preparation of a nasal gel (the “Gel”) to be applied to the sinus cavities via a supplied applicator syringe and specifically designed malleable cannula.

One Chitogel Endoscopic Sinus Surgery Kit contains:

  • Sealed vial A containing 12ml Sodium Phosphate buffer solution
  • Sealed vial B containing 350mg Dextran Aldehyde powder
  • Sealed vial C containing 12ml Chitosan Succinamide solution

  • Fluid dispensing connector
  • Two (2) mixing cannulae
  • Malleable cannula
  • Two (2) sterile 20ml Luer Lock syringes
There are two main components to the Gel.
  1. Dextran Aldehyde (B), which is a dry powder, and is reconstituted into a liquid form by mixing the powder with a liquid Sodium Phosphate Buffer (A). Both of these components are supplied sterile.
  2. The second main component, Chitosan Succinamide (C), is a liquid and is also supplied sterile.

The components of the Gel must be combined following the detailed Gel Combination Instructions outlined below and in the instructions for use.

General Instructions

The Gel preparation and setting time will take approximately 30 minutes, so preparation must start sufficiently in advance of when the Gel is expected to be used in surgery. The components of the Gel need to be combined following the detailed Gel Combination Instructions.

Once the Gel has been prepared it should be applied to the sinus cavities on both sides within one hour using the malleable cannula supplied with the Kit.

Gel Combination Instructions

The Gel preparation and setting time will take approximately 30 minutes, so preparation must start sufficiently in advance of when the Gel is expected to be used in surgery.

3-Step Gel Preparation

  • The kit will make 20ml of gel, enough to fill both sides
  • Gel prep takes about 30 minutes, and must be applied within 6 hours
  • Chitogel CAN and SHOULD be prepped early in the case

Step 1: PREPARATION

  • Mix sodium phosphate (A) with dextran (B), shake 20 seconds
  • Aspirate AB into first syringe
  • Aspirate chitosan (C) into second syringe
  • Wait at least 15 minutes

Step 2: MIX GEL

  • Attach syringes using fluid dispensing connector
  • Mix AB with C, repeating at least 6 times
  • Wait at least 15 minutes for gel to set

Step 3: APPLY

  • Split the gel evenly between the two syringes (10 ml of gel in each)
  • Use the malleable cannula to apply to sinus cavity at desired angles

Instructions For Use

Download the below PDF for detailed instructions on gel preparation.

v2.92 IFU CSK-4 US Letter

How to apply

When applying Chitogel it is important to apply the gel to all areas in a specific sequence.

10mls of Chitogel is to be applied to each side. In order apply firstly to the frontal sinus. 

Bend the tip of the malleable cannula for the angle required to place accurately into the frontal ostium. Next place Chitogel into the sphenoids sinus, then fill the ethmoid sinuses in a posterior to anterior direction, and then around the maxillary ostium. Lastly apply to the space between the anterior end of the middle turbinate and the lateral nasal wall.

It’s important to leave space in the floor of the nose so the patient will have a bilateral nasal airway (see the below videos).

Chitogel with good post-op irrigation

Chitogel with patient with narrow frontal ostium

Chitogel with previous surgery

Chitogel applied to frontal drillout

Chitogel compared to nothing at one week

Chitogel compared to nothing

Post-Operative Care

The patient should be advised to undertake normal saline nasal washes 4–6 times per day for two weeks following surgery.

The patient should be advised that the nasal washing should be conducted using a normal nasal saline washing solution and each wash should use approximately 8 ounces / 240ml. The patient must have a post operative review by the surgeon, within 1–2 weeks of the surgery. At the first post-operative review by the surgeon, any remaining Gel in the sinus cavity should be removed, ideally with suction.

Trouble shooting

Complications associated with not irrigating sinuses post-operatively.

It is imperative that the sinuses are irrigated on a regular basis from the first post-operative day. We advise using 240mls of saline douche, 4-6 times daily for the first 2 weeks after surgery. Failure to do so can result in the Gel forming into a crust.

If this occurs then careful debridement of the crust and removal should be performed by the surgeon at the 2 week post operative review, and saline irrigations commenced.

 

Maintain clear breathing passages.

If after application of the Gel there is too much Gel in the floor of the nose for the patient to breath through, careful suctioning along the floor of the nose is recommended to remove the excess Gel.

Control excessive bleeding before applying

At the end of the surgery, it is important that any active bleeding is controlled, as you would normally, prior to application of the Gel. Bipolar cautery is used to control active bleeding. This must be done before placement of the Gel, to avoid the risk that the Gel may be “washed” out of the sinuses by significant bleeding.

Precautions

  • Verify that the surgical field is not bleeding excessively. Control excessive bleeding, as you would normally, prior to application of the Chitogel Endoscopic Sinus Surgery Kit material.
  • Inspect the packaging to be sure that it is intact and undamaged prior to use. Do not use the product if the packaging is opened or damaged.
  • Do not reuse or resterilize Chitogel Endoscopic Sinus Surgery Kit.
  • Inspect the Kit contents prior to use. Do not use the product if any of the sealed vials appear to have been opened or to have leaked, or if any of the components of the Kit appear to be damaged.

Warnings

  • Chitogel Endoscopic Sinus Surgery Kit contains chitosan from shellfish and should not be used in patients with known allergic responses to shellfish. Physicians should test for shellfish allergic response if status unknown, prior to use.
  • The Chitogel Endoscopic Sinus Surgery Kit should not be used in surgery involving any of the following complications:— Any form of cerebrospinal fluid leak; or— Any form of ophthalmic complication, including but not limited to orbital hemorrhage or hematoma and exposure of the orbital tissues.
  • In rare instances, the physiochemical condition associated with Functional Endoscopic Sinus Surgery (FESS), both with and without material application, may present a risk of toxic shock syndrome (TSS). Warning signs of TSS include: sudden fever (usually 39°C or more), vomiting, diarrhea, dizziness, fainting (or near fainting when standing up), and/or a rash that looks like a sunburn.
  • Foreign body reaction may occur as with most surgical adjuvant treatments.
  • Chitogel Endoscopic Sinus Surgery Kit must be used according to the instructions for use. Read instructions prior to use.