Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06260618
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-01-31
Brief Title:
Effect of Chitodex Gel in Tympanoplasty Surgery
Sponsor:
Central Adelaide Local Health Network Incorporated
Organization:
Central Adelaide Local Health Network Incorporated
Study Overview
Official Title:
A Single-blinded Randomised Trial Evaluating the Efficacy of Chitosan-dextran Chitodex Gel Versus Gelfoam Sponge Instillation Within the Middle Ear and External Auditory Canal During Tympanoplasty Surgery
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 procedures to close tympanic membrane perforations TMP
Detailed Description:
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 procedures to close tympanic membrane perforations TMP The investigators aim to compare the success rates of tympanoplasty surgery between the two products The ultimate goal is to identify the ME packing agent-of-choice to ensure TMP closure as well as minimal inflammation of the middle ear mucosa The most critical measure of success during tympanoplasty surgery is the closure of a chronic pre-existing TMP As such the primary outcome will be a measure of tympanic membrane closure This is performed under direct vision during routine post-operative surveillance via the use of either a hand-held otoscope or an operating otologic microscope The investigators will perform this check at 4 distinct time-points 2 and 6 weeks post-op 3 months post-op and 6 months post-op
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
Fidelity of the interventions is measured in several ways by the surgeon at the end of the operation A good seal for the graft is always assessed for by the surgeon prior to completing any tympanoplasty This is determined via any evidence of air escape from the middle ear when palpating the tympanic membrane and graft at the end of the procedure A good seal indicates a well-positioned graft The surgeons operative notes will indicate this The investigators will also obtain endoscopic images and videos at the end of procedure to assess positioning of the graft
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
Fidelity of the interventions is measured in several ways by the surgeon at the end of the operation A good seal for the graft is always assessed for by the surgeon prior to completing any tympanoplasty This is determined via any evidence of air escape from the middle ear when palpating the tympanic membrane and graft at the end of the procedure A good seal indicates a well-positioned graft The surgeons operative notes will indicate this The investigators will also obtain endoscopic images and videos at the end of procedure to assess positioning of the graft
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None