Clinical trial NCT04783233: Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery
Official title: The Use of Chitosan Succinamide (Chitogel CSK-4) Gel as Packing in Tympanoplasty Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tympanoplasty Surgery
Keywords: Chitogel
Tympanoplasty
Support material
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for primary tympanoplasty surgery.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Single tympanic membrane perforation

Exclusion Criteria:

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

Primary outcomes:
measure: External auditory canal healing
timeFrame: Assess healing of auditory canal starting 1 week up to one year following surgery.
measure: Tympanic membrane healing
timeFrame: Assess healing of auditory canal starting 1 week up to one year following surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Novi
country: United States
facility: Ascension Providence Hospital Novi Campus
state: Michigan
Study officials:
affiliation: Physician of Record
name: Brent Wilkerson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.