Tympanoplasty SurgeryNCT04783233
Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery
An observational study of Tympanoplasty Surgery, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Tympanoplasty Surgery
- What is being tested?
- Chitosan succinamide and Gelfoam
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2021to 3 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for primary tympanoplasty surgery.
Who may be able to join
- Healthy adults
- Single tympanic membrane perforation
Who cannot join
- Chronic recurrent infection or otorrhea
- Previous ear surgery for the study ear
- Shellfish allergy
- Cerebral Spinal Fluid (CSF) leak concern
Trial locations and contacts
1 site in 1 country.
United States1 site
Ascension Providence Hospital Novi Campus
Novi, Michigan, 48374
About this study
Official title: The Use of Chitosan Succinamide (Chitogel CSK-4) Gel as Packing in Tympanoplasty Surgery
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.
Read the detailed description
A prospective cohort study will be performed. Healthy adults (age > 18) with single tympanic membrane perforations who have been offered and agreed to undergo tympanoplasty surgery with fascia graft (either transcanal or post-auricular) will be recruited. The surgical intervention and procedure of tympanoplasty will be performed as normal, however, the packing material will be randomly chosen using a random number generator. The middle ear and external canal will then be packed with either Chitosan Succinamide or Gelfoam. The patients in both groups will be placed on ciprodex post-operatively for 4 weeks. The patients will be seen post-operatively at 1 week for photo documentation and removal of the lateral aspect of CS/CD or Gelfoam. The patients will be seen at 4 weeks for photo documentation and the remainder of packing removal. At 3 months and 1 year the patients will have photo documentation and an audiogram.
- Conditions
- Tympanoplasty Surgery
- Being tested
- Chitosan succinamide, Gelfoam
- Keywords
- Chitogel, Tympanoplasty, Support material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chitosan succinamideBiological
Also called Chitogel, CSK-4
Chitogel will be tested for suitability as a packing material in tympanoplasty surgery.
GelfoamBiological
Gelfoam is the current packing material for tympanoplasty surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Chitosan succinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
External auditory canal healing
Physician determines exposed bone and inflammatory response
Measured: 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.
Measured: Assess healing of auditory canal starting 1 week up to one year following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start14 Jan 2021
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
Why it stopped: Physician left practice.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tympanoplasty SurgeryStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brent Wilkerson, MD, Principal investigator, Physician of Record
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783233
- Sponsor's protocol ID
- 1685638
- Status last verified
- Jan 2022
- First submitted
- 26 Jan 2021
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20109331Ngoc 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.
PubMed 23322408Dogru 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.
PubMed 19201284
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Chitosan Succinamide (Chitogel CSK-4) Gel as Packing in Tympanoplasty Surgery
- ClinicalTrials.gov ID
- NCT04783233
- Acronym / sponsor ID
- 1685638
- Conditions
- Tympanoplasty Surgery
- Keywords
- Chitogel, Tympanoplasty, Support material
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Physician left practice.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective cohort study will be performed. Healthy adults (age > 18) with single tympanic membrane perforations who have been offered and agreed to undergo tympanoplasty surgery with fascia graft (either transcanal or post-auricular) will be recruited. The surgical intervention and procedure of tympanoplasty will be performed as normal, however, the packing material will be randomly chosen using a random number generator. The middle ear and external canal will then be packed with either Chitosan Succinamide or Gelfoam. The patients in both groups will be placed on ciprodex post-operatively for 4 weeks. The patients will be seen post-operatively at 1 week for photo documentation and removal of the lateral aspect of CS/CD or Gelfoam. The patients will be seen at 4 weeks for photo documentation and the remainder of packing removal. At 3 months and 1 year the patients will have photo documentation and an audiogram.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Packing with Gelfoam | – | Biological: GelfoamTympanoplasty surgery with fascia graft (either transcanal or post-auricular) will be preformed. The middle ear and external canal will then be packed with Gelfoam. |
| Packing with Chitosan succinamide | – | Biological: Chitosan succinamideThe surgical intervention and tympanoplasty will be performed as normal. The middle ear and external canal will be packed Chitosan succinamide. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for primary tympanoplasty surgery.
Key inclusion criteria (2 listed)
- Healthy adults
- Single tympanic membrane perforation
Key exclusion criteria (4 listed)
- Chronic recurrent infection or otorrhea
- Previous ear surgery for the study ear
- Shellfish allergy
- Cerebral Spinal Fluid (CSF) leak concern
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chitosan succinamideAlso: Chitogel, CSK-4Chitogel will be tested for suitability as a packing material in tympanoplasty surgery. | Biological | Packing with Chitosan succinamide |
| GelfoamGelfoam is the current packing material for tympanoplasty surgery. | Biological | Packing with Gelfoam |
Primary outcome
External auditory canal healing
Time frame: Assess healing of auditory canal starting 1 week up to one year following surgery.
Physician determines exposed bone and inflammatory response
Tympanic membrane healing
Time frame: Assess healing of auditory canal starting 1 week up to one year following surgery.
Physician determines failed tympanic membrane healing and inflammatory response.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 20109331Valentine 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.
- Background: PubMed 23322408Ngoc 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.
- Background: PubMed 19201284Dogru 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent Wilkerson, MD principal investigator
Physician of Record
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tympanoplasty Surgery, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
External auditory canal healing (time frame: Assess healing of auditory canal starting 1 week up to one year following surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04783233, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.