Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Gelfoam
  • Chitodex

Treatment groups

44 Participants
are divided into 2 treatment groups

Locations

2
The Queen Elizabeth Hospital5011, AdelaideSouth Australia, Australia
The Memorial Hospital5006, North AdelaideSouth Australia, Australia

Sponsors and collaborators

Central Adelaide Local Health Network Incorporated

Lead sponsor

University of Adelaide

Collaborator

Source ClinicalTrials.gov