NCT04783233

Brief Summary

Little innovation in the material used for middle ear packing has occurred over the past decade, despite the fact that animal models have shown increased acute inflammation and increased fibrosis in the long term histologically. Although Chitosan Succinamide has shown improved wound healing and hemostasis in the nasal cavity mucosa, it has yet to be used as a support material, hemostatic agent, and healing agent in the middle ear. This study will utilize Chitosan Succinamide as an alternative to purified gelatin foam as a support material in primary tympanoplasty surgery.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2021

Completed
Last Updated

December 19, 2025

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

January 26, 2021

Last Update Submit

December 15, 2025

Conditions

Tympanoplasty Surgery

Keywords

ChitogelTympanoplastySupport material

Outcome Measures

Primary Outcomes (2)

  • External auditory canal healing

    Physician determines exposed bone and inflammatory response

    Assess healing of auditory canal starting 1 week up to one year following surgery.

  • Tympanic membrane healing

    Physician determines failed tympanic membrane healing and inflammatory response.

    Assess healing of auditory canal starting 1 week up to one year following surgery.

Study Arms (2)

Packing with Gelfoam

Tympanoplasty surgery with fascia graft (either transcanal or post-auricular) will be preformed. The middle ear and external canal will then be packed with Gelfoam.

Biological: Gelfoam

Packing with Chitosan succinamide

The surgical intervention and tympanoplasty will be performed as normal. The middle ear and external canal will be packed Chitosan succinamide.

Biological: Chitosan succinamide

Interventions

Chitosan succinamideBIOLOGICAL

Chitogel will be tested for suitability as a packing material in tympanoplasty surgery.

Also known as: Chitogel, CSK-4
Packing with Chitosan succinamide
GelfoamBIOLOGICAL

Gelfoam is the current packing material for tympanoplasty surgery.

Packing with Gelfoam

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients eligible for primary tympanoplasty surgery.

You may qualify if:

  • Healthy adults
  • Single tympanic membrane perforation

You may not qualify if:

  • Chronic recurrent infection or otorrhea
  • Previous ear surgery for the study ear
  • Shellfish allergy
  • Cerebral Spinal Fluid (CSF) leak concern

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ascension Providence Hospital Novi Campus

Novi, Michigan, 48374, United States

Location

Related Publications (3)

  • Valentine R, Athanasiadis T, Moratti S, Hanton L, Robinson S, Wormald PJ. The efficacy of a novel chitosan gel on hemostasis and wound healing after endoscopic sinus surgery. Am J Rhinol Allergy. 2010 Jan-Feb;24(1):70-5. doi: 10.2500/ajra.2010.24.3422.

    PMID: 20109331BACKGROUND

  • Ngoc Ha T, Valentine R, Moratti S, Robinson S, Hanton L, Wormald PJ. A blinded randomized controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jul;3(7):573-80. doi: 10.1002/alr.21136. Epub 2013 Jan 16.

    PMID: 23322408BACKGROUND

  • Dogru S, Haholu A, Gungor A, Kucukodaci Z, Cincik H, Ozdemir T, Sen H. Histologic analysis of the effects of three different support materials within rat middle ear. Otolaryngol Head Neck Surg. 2009 Feb;140(2):177-82. doi: 10.1016/j.otohns.2008.10.023.

    PMID: 19201284BACKGROUND

MeSH Terms

Interventions

Gelatin Sponge, Absorbable

Intervention Hierarchy (Ancestors)

Surgical SpongesSurgical EquipmentEquipment and Supplies

Study Officials

  • Brent Wilkerson, MD

    Physician of Record

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

March 5, 2021

Study Start

January 14, 2021

Primary Completion

November 3, 2021

Study Completion

November 3, 2021

Last Updated

December 19, 2025

Record last verified: 2022-01

Locations

US(1)