Effect of Chitodex Gel in Tympanoplasty Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Adelaide Local Health Network Incorporated
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 groupsSponsors and collaborators
Central Adelaide Local Health Network Incorporated
Lead sponsor
University of Adelaide
Collaborator
Source ClinicalTrials.gov