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Chitogel versus Hydrogel on wound healing and patient experience following endosopic sinus surgery

A Randomised controlled study to evaluate the effect of Chitogel versus Hydrogel on wound healing and patient experience following endosopic sinus surgery

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001336875
Enrollment
30
Registered
2021-10-05
Start date
2022-03-28
Completion date
Unknown
Last updated
2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Endoscopic Sinus Surgery (ESS) has a crucial role in the management of chronic rhinosinusitis (CRS), however post-operative scaring and adhesion is a significant cause of surgical failure. Chitosan-Dextran Gel (Chitogel) has been shown to be an effective haemostatic nasal packing following ESS which reduces adhesion formation and stenosis of sinus ostia. It has also been shown to promote healing up to even 12 months following surgery, as demonstrated by reduced oedema, granulation and pus formation when compared to no packing. The purpose of this study is to evaluate the effect of Chitogel against the current standard of nasal packing being used; Hydrogel (PureRegen Gel Sinus), on post-operative wound healing and patient experience. We will compare the effect of Chitogel with hydrogel (PureRegen Gel Sinus) being used at our institution. Our hypothesis is that use of Chitogel will yield different endoscopic appearances of the sinuses at post operative 2-week, and 3-month follow up checks.

Interventions

Chitogel is a postoperative hydrogel nasal dressing that can be applied to sinuses after endoscopic sinus surgery. The hydrogel is made by combining Chitosan, Dextran and Glycerol. Chitogel has been shown to be an effective haemostatic nasal packing following endoscopic sinus surgery which reduces adhesion formation and stenosis of sinus ostia. It has also been shown to promote healing up to even 12 months following surgery, as demonstrated by reduced oedema, granulation and pus formation when c

Chitogel is a postoperative hydrogel nasal dressing that can be applied to sinuses after endoscopic sinus surgery. The hydrogel is made by combining Chitosan, Dextran and Glycerol. Chitogel has been shown to be an effective haemostatic nasal packing following endoscopic sinus surgery which reduces adhesion formation and stenosis of sinus ostia. It has also been shown to promote healing up to even 12 months following surgery, as demonstrated by reduced oedema, granulation and pus formation when compared to no packing. The Chitogel is applied endonasally once, by the operating ear, nose and throat surgeon, at the end of surgery upon completion of the procedure. The gel comes in two components which are combined according to producer instruction manual. The gel is applied to the sinus cavity using a syringe and malleable cannula. 5-10mL will be applied, the same as the amount of Hydrogel (comparator) used. Endoscopic sinus surgery on average will take approximately 2 hours. Theatre staff will monitor that the application protocol is followed.

Sponsors

North Shore Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients undergoing bilateral Functional ESS for CRS

Exclusion criteria

Allergy to shellfish Pregnancy/breast feeding Previous sinus surgery

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026