Effect of Chitodex Gel in Tympanoplasty Surgery

NCT06260618 | Recruiting

• 1 other identifier: 2021/HRE00065
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty, ossiculoplasty and mastoidectomy procedures.

Conditions

Tympanic Membrane Perforation; Tympanic Membrane Inflammation; Surgery; Otitis Media

Keywords

tympanic membrane; surgery; single blinded; chitogel; chitosan-dextran; otitis media; gelfoam; medical device; chitodex; myringoplasty; mastoidectomy; ossiculoplasty

Outcome Measures

Primary Outcomes (2)

• Number of participants with tympanic membrane closure

  tympanic membrane closure will be assessed via otoscopy (images will be captured via the otoscopic equipment)

  Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively

• rate of tympanic membrane closure

  Time taken for tympanic membrane to close, assessed by otoscopy (images will be captured via the otoscopic equipment)

  Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively

Secondary Outcomes (6)

• Number of participants with improved hearing

  Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively

• Number of participants with improved eardrum function

  Pre-operatively, and 3 months and 6 months post-operatively

• Ease of use of product compared to active comparator - surgeon feedback

  Once, on day of surgery (within 6 hours post-operatively)

• Time taken to complete surgery

  Once, for the duration of the operation (hours)

• Number of Participants with improved quality of life

  Pre-operatively, and 2 weeks, 6 weeks, 3 months and 6 months post-operatively

Study Arms (2)

Gelfoam Arm

ACTIVE COMPARATOR

The current standard of care in middle ear packing material has been Gelfoam, Gelfoam is an absorbable gelatin sponge manufactured from denatured porcine skin. Generally, Gelfoam resides within the middle ear for 2 to 9 weeks prior to being degraded via phagocytosis. A single Gelfoam sponge is divided into small pieces and used within the ear. One piece of Gelfoam can typically be cut into over 200 smaller pieces. The surgeon uses approximately 10 to 20 of these smaller pieces per surgery. Approx a third of the product is applied into the middle ear, as a support material for the graft. After graft suturing is complete, the remaining two thirds are applied into the external ear canal as a packing agent. The surgeon administers the foam during the surgery as they would with the standard TMP repair surgery. The product comes in a sterile package to be opened and cut up by Scrub Nurse.

Device: Gelfoam

Chitodex Arm

EXPERIMENTAL

Chitosan-dextran gel is packaged within a syringe and has a cannula attached, much like the Gelfoam syringe system. Approx 3-5mL of product is applied during the surgery. Approx 2mL into the middle ear, as a support material for the graft. After graft suturing is complete, another 3mL (approx) is applied into the external ear canal as a packing agent. This is the same procedure as Gelfoam is currently used for this purpose. The surgeon will administer the gel during the surgery as they would with the standard of care Gelfoam. The product comes in a sterile kit to be opened by Scrub Nurse.

Device: Chitodex

Interventions

Gelfoam DEVICE

GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine skin, Gelatin USP Granules and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids.

Also known as: Gelfoam® absorbable gelatin compressed sponge, USP

Gelfoam Arm

Chitodex DEVICE

The Chitogel Endoscopic Sinus Surgery Kit contains components and equipment for the preparation of a nasal gel to be applied to the sinus cavities via a supplied and specifically designed malleable cannula. The Gel preparation will take approximately 30 minutes, so preparation must start sufficiently in advance of when the Gel is expected to be used in surgery. Once the Gel has been prepared it should be applied to the sinus cavities on both sides within six hours using the malleable cannula supplied with the Kit. The Gel must be prepared on a sterile surface following these instructions. There are two main components to the Gel. 1. Dextran Aldehyde (B), which is a dry powder, and is reconstituted into a liquid form through mixing the powder with a liquid Sodium Phosphate Buffer (A). Both of these components are supplied sterile. 2. The second component Chitosan Succinamide (C), is a liquid and is also supplied sterile.

Also known as: Chitosan-Dextran, Chitogel Endoscopic Sinus Surgery Kit

Chitodex Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who have otoscopic evidence of tympanic membrane perforation that is also confirmed by tympanometry (Defined as a Type B tympanogram, with elevated EAC volume) AND
• The TM perforation is associated with at least 15dB of conductive hearing loss on the affected side AND
• Are indicated to undergo closure of the perforation via tympanoplasty surgery
• OR Individuals who are indicated for ossiculoplasty due to ossicular chain disruption and its sequelae
• OR Individuals who are indicated for mastoidectomy for COM or its sequelae eg cholesteatoma
• Demonstrate healthy, dry middle ear mucosal cavities at time of surgery AND
• Are 18 years of age or over AND
• Are able to give written informed consent AND
• Are committed to returning for post-operative assessments at 2 and 6 weeks post-op, 3-, and 6- months post-op

You may not qualify if:

• Operative ear is the better or only hearing ear
• The ear has evidence of cholesteatoma or other middle ear tumour during otoscopic examination
• dysfunction during otoscopic and tympanometric examination
• Known allergy to shellfish or ciprofloxacin antibiotics
• Pregnant or breastfeeding
• Hepatitis, HIV or any blood disorders
• COVID-19 positive patients
• Contra-indications for MRI

Sponsors & Collaborators

• Central Adelaide Local Health Network Incorporated: lead
• University of Adelaide: collaborator

Study Sites (2)

The Queen Elizabeth Hospital

Adelaide, South Australia, 5011, Australia

RECRUITING

The Memorial Hospital

North Adelaide, South Australia, 5006, Australia

RECRUITING

MeSH Terms

Conditions

Tympanic Membrane Perforation; Otitis Media

Interventions

Gelatin Sponge, Absorbable

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries; Otitis

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies

Study Officials

• Prof Peter-John Wormald, MD

  Central Adelaide Local Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof Peter-John Wormald, MD,

CONTACT

+61 8 82227158; pjwormald@gmail.com

Emma Barry, BSc (Hons)

CONTACT

+61 8 82227158; emma.barry@adelaide.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masked: The people receiving the treatment/s, The people analysing the results/data Unmasked: The surgeon administering the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Peter John Wormald MD, FAHMS, FRACS, FACS, FCS(SA), FRCS (Ed), MBChB Chairman Otolaryngology Head and Neck Surgery Professor of Skull Base Surgery , CAHLN and University of Adelaide

Model Details: Single blinded randomised clinical trial

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 15, 2024
• Study Start: November 20, 2021
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)