Comparison of Chitodex Gel Vs NexFoam on Post-operative O... | NCT05083741

Studies
Comparison of Chitodex Gel Vs NexFoam on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis

NCT05083741

Sponsor

St. Louis University

Status

Terminated

Last Update Posted

Sep 19, 2024Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Chronic Rhinosinusitis

Interventions

Chitogel
Nexfoam

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of recruitment and usable data

Expanded Access Info

Start Date

Dec 27, 2021Actual

Primary Completion Date

Aug 8, 2024Actual

Completion Date

Aug 8, 2024Actual

First Submitted Date

Oct 6, 2021

First Submission Date that Met QC Criteria

Oct 6, 2021

First Posted Date

Oct 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare the efficacy and outcomes of Chitodex gel plus Kenalog versus Nexfoam plus Kenalog in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery. Both dressings are already known to be beneficial in controlling postoperative bleeding and promote wound healing.

Detailed Description

The trial will be single blinded randomized controlled trial and patients recruited will undergo endoscopic sinus surgery as standard of care for treatment of CRS. Specific outcome measures will be objective and subjective outcome scores post surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chitogel		Chitodex gel plus Kenalog inserted into the middle meatus	Device: Chitogel
Nexfoam		NexFoam plus Kenalog inserted into the middle meatus	Device: Nexfoam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chitogel	Device	post-operative dressing within standard of care	Chitogel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Scores on Endoscopy	Outcome measured based on the wound healing in the sinus openings made during surgery.	12 (±2) weeks post surgery

Secondary Outcomes

Measure	Description	Time Frame
Symptom Scores on Patients' Self-Directed Questionnaires	Outcomes measured based on patients' personal symptom assessment.	12 (±2) weeks post surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND
≥ 18 years to ≤ 90 years AND
English speaking AND
Able to give written informed consent AND
Local residents who will be returning to this center for postoperative follow-up care AND
Indicated to undergo endoscopic sinus surgery and willing to return at 2-4, 6-8 & 12 (± 2) weeks post-op.

Exclusion Criteria:

allergy to shellfish
pregnant or breastfeeding
Hepatitis or blood disorders
any drug allergy
allergy to potato starch (due to Nexfoam)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

SLUCare Otolaryngology Clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph D Brunworth, MD	Department of Otolaryngology-Head & Neck Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Louis University		St Louis	Missouri	63104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23322408	Background	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.
19178792	Background