Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001013459
Ethics application status
Approved
Date submitted
30/07/2025
Date registered
12/09/2025
Date last updated
12/09/2025
Date data sharing statement initially provided
12/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trial of Chitogel/Deferiprone patch to assess post operative epidural fibrosis in patients undergoing lumbar spinal surgery
Scientific title
Trial of Chitogel/Deferiprone patch to assess post operative epidural fibrosis in patients undergoing lumbar spinal surgery
Secondary ID [1] 315036 0
CT-2023-CTN-03907-1.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epidural fibrosis post spinal surgery 338380 0
Condition category
Condition code
Surgery 334685 334685 0 0
Other surgery
Musculoskeletal 334803 334803 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Methodology
Ethics
This study was approved by the Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC), approval number 2022/HRE00088. Clinical trial notification through the Therapeutic Goods Administration number CT-2023-CTN-03907-1. All participants provided written informed consent prior to enrolment, and the study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines.

Surgical Procedure
The procedure would involve a decompressive lumbar laminectomy at the affected level/s with rhizolysis of the affected nerve root/s with consideration for microdiscectomy if indicated.

Materials
Chitogel
The current commercially produced formulation of Chitogel® (Chitogel, Wellington, NZ) was used. Chitogel is made up of a combination of three components; 5% succinyl-chitosan, 0.3% phosphate buffer which includes glycerol and 3% dextran aldehyde. The components are manufactured and sterilized by Chitogel. All stocks were stored at room temperature.

Deferiprone
European Pharmacopoeia grade Deferiprone (3-hydroxy-1,2-dimethylpyridin-4(1H)-one) (Sigma-Aldrich, St Louis, USA) was stored at room temperature. Royal Adelaide Hospital Pharmacy compounded 4mM of sterile Deferiprone.

Preparation of Chitogel and Deferiprone
Preparation involved opening a sterile Chitogel kit on the operating table by the scrub nurse at the beginning of the surgery. The Chitogel and Deferiprone were prepared by the scrub nurse.

A sterile study kit was compounded by the Royal Adelaide Hospital Pharmacy in advance and contained the following: 12ml 0.3% Sodium Phosphate buffer solution (Vial A), 350mg Dextran Aldehyde powder (Vial B), 12ml 5% Chitosan Succinamide solution (Vial C) and 4ml Deferiprone 4mM sterile solution.

The preparation steps were as follows: Using a mixing cannula and 20 mL syringe, remove and discard 8.8 mL of chitosan succinamide from Vial C. Mix Vial A into Vial B together and shake for 20 seconds. Draw 8.8ml of the newly mixed Vial A/B solution and add to Vial C. Transfer 4ml of Deferiprone solution into vial C, making 16ml of 1% Deferiprone and 1% chitosan. Draw up the required volume based on the number of levels (~3ml per operative level) and allow to set as a gel for 5 minutes, then administer.

Preparation of the Chitogel-Def gel commenced once the operation was finished while the surgeon was achieving haemostasis prior to closure. The neurosurgeon performing the procedure applied the gel at the conclusion of the operation. The gel was applied onto the dura and nerve root, aiming for at least 3ml of gel per level.
Intervention code [1] 331631 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342354 0
Safety. Wound infection requiring treatment
Timepoint [1] 342354 0
6 months post operatively
Secondary outcome [1] 450464 0
Self rated questionnaire of leg pain and back pain. (Lumbar Spine Outcomes Questionnaire form).
Timepoint [1] 450464 0
6 months post surgery
Secondary outcome [2] 450829 0
Post operative epidural fibrosis on MRI scan
Timepoint [2] 450829 0
12 weeks post surgery

Eligibility
Key inclusion criteria
Include age over 18 and planned for a first time decompressive lumbar surgery for compression of lumbosacral nerve roots causing radiculopathy.
Significant pain and symptoms measurable by the Lumbar Spine Outcomes Questionnaire (LSOQ). Leg pain must be the predominant symptom, and must be supported by radiological evidence of associated nerve root compression. This would constitute MRI or CT myelogram evidence of compression of a nerve root secondary to a combination of: ligamentum flavum hypertrophy, facet joint hypertrophy or extruded disc contents. The source of neural element compromise should be clear and pathology should be limited to a single level.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclude age <18, inability to provide direct informed consent, previous spine surgery at lumbar level, significant multi-level degenerative spondylosis that could contribute to back and/or leg pain in a clinically significant way, facet joint arthropathy confirmed on imaging or previous history of facet joint injections/ablation, significant foraminal stenosis,

extraforaminal pathology, spondylolisthesis with foraminal stenosis, use of epidural steroids in the 4 weeks prior to surgery or peri/intra-operative use of oral corticosteroids, significant back pain as primary complaint, pregnancy, breast-feeding, malignancy within previous 5 years, auto-immune disease, history of iron overload conditions, use of oral deferiprone during the study time. Patients with a shellfish allergy are to be excluded. Intraoperative exclusions include intraoperative durotomy or decision to place instrumentation. A post operative wound drain on free or suction drainage is not exclusion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Descriptive statistics were used to summarise baseline characteristics, operative details, and outcome measures. Continuous variables were reported as means with standard deviations, and categorical variables as counts and percentages.

A paired samples t-test was used to compare preoperative and 6-month postoperative scores from the Lumbar Spine Outcomes Questionnaire (LSOQ) across each of its five domains (back pain, leg pain, functional disability, physical symptoms, and psychological distress), to assess for statistically significant within subject improvements.

To evaluate the primary safety endpoint, the observed postoperative wound infection rate in the study cohort was compared to the expected population rate (5%) using a one-sample binomial test. A power calculation demonstrated that a sample size of 20 patients provided >80% power to detect a clinically unacceptable increase in complication rate to 25%, at a one-sided alpha of 0.05.

Exploratory analyses were conducted to evaluate associations between MRI fibrosis burden and postoperative symptom severity. Pearson’s and Spearman’s correlation coefficients were used to assess relationships between the continuous composite MRI fibrosis score and postoperative leg pain scores. Additionally, independent-samples t-tests were used to compare mean postoperative leg pain scores between patients classified as having “extensive scarring” (based on the Ross et al. criteria) and those without. All statistical analyses were performed using IBM SPSS Statistics (version 30), with significance defined as p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2023
Date of last participant enrolment
Anticipated
Actual
28/10/2024
Date of last data collection
Anticipated
Actual
1/06/2025
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 28260 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 28261 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 44472 0
5000 - Adelaide
Recruitment postcode(s) [2] 44473 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 319599 0
Government body
Name [1] 319599 0
NHMRC
Country [1] 319599 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 322101 0
None
Name [1] 322101 0
Address [1] 322101 0
Country [1] 322101 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318164 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 318164 0
Ethics committee country [1] 318164 0
Australia
Date submitted for ethics approval [1] 318164 0
05/08/2022
Approval date [1] 318164 0
17/04/2023
Ethics approval number [1] 318164 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143318 0
Prof Peter-John Wormald
Address 143318 0
Department of Otolaryngology Head and Neck Surgery Level 3C Queen Elizabeth Hospital 28 Woodville Road Woodville South SA 5011
Country 143318 0
Australia
Phone 143318 0
+61 8 8222 7158
Fax 143318 0
Email 143318 0
[email protected]
Contact person for public queries
Name 143319 0
Nicholas Candy
Address 143319 0
Department of Otolaryngology Head and Neck Surgery Level 3C Queen Elizabeth Hospital 28 Woodville Road Woodville South SA 5011
Country 143319 0
Australia
Phone 143319 0
+61 432605173
Fax 143319 0
Email 143319 0
[email protected]
Contact person for scientific queries
Name 143320 0
Nicholas Candy
Address 143320 0
Department of Otolaryngology Head and Neck Surgery Level 3C Queen Elizabeth Hospital 28 Woodville Road Woodville South SA 5011
Country 143320 0
Australia
Phone 143320 0
+61 432605173
Fax 143320 0
Email 143320 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.