Effect of Chitodex Gel in Tympanoplasty Surgery

NARecruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

November 20, 2021

Primary Completion Date

May 13, 2025

Study Completion Date

May 13, 2025

Conditions
Tympanic Membrane PerforationTympanic Membrane InflammationSurgeryOtitis Media
Interventions
DEVICE

Gelfoam

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.

DEVICE

Chitodex

"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."

Trial Locations (2)

5006

RECRUITING

The Memorial Hospital, North Adelaide

5011

RECRUITING

The Queen Elizabeth Hospital, Adelaide

All Listed Sponsors
collaborator

University of Adelaide

OTHER

lead

Central Adelaide Local Health Network Incorporated

OTHER_GOV