Evidence map›Paper›PMID 41272194›Full record

ArticleEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2026

Phase I trial to evaluate safety of Deferiprone-Chitogel to prevent epidural fibrosis in lumbar spine surgery.

Nicholas G Candy, Emma F Barry, Vanesa M Tomatis, Sandy Patel, Jamie Miller, Christopher Ovenden, Jake Nowicki, Elie Hammam, Santosh Poonnoose, Simon Sandler and 3 more

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Nicholas G CandyDepartment of Surgery - Otolaryngology Head and Neck Surgery, University of Adelaide, Adelaide, Australia. Nicholas.candy@adelaide.edu.au.ORCID 0000-0002-8826-1840
Emma F BarryDepartment of Surgery - Otolaryngology Head and Neck Surgery, University of Adelaide, Adelaide, Australia.
Vanesa M TomatisDepartment of Neurosurgery, Flinders Medical Centre, Bedford Park, Adelaide, Australia.
Sandy PatelDepartment of Radiology, Jones and Partners, Calvary, Adelaide, Australia.
Jamie MillerDepartment of Neurosurgery, Flinders Medical Centre, Bedford Park, Adelaide, Australia.
Christopher OvendenDepartment of Neurosurgery, Flinders Medical Centre, Bedford Park, Adelaide, Australia.
Jake NowickiDepartment of Neurosurgery, Royal Adelaide Hospital, Adelaide, Australia.
Elie HammamDepartment of Neurosurgery, Royal Adelaide Hospital, Adelaide, Australia.
Santosh PoonnooseDepartment of Neurosurgery, Flinders Medical Centre, Bedford Park, Adelaide, Australia.
Simon SandlerDepartment of Neurosurgery, Royal Adelaide Hospital, Adelaide, Australia.
Adam WellsDepartment of Neurosurgery, Royal Adelaide Hospital, Adelaide, Australia.
Sarah VreugdeDepartment of Surgery - Otolaryngology Head and Neck Surgery, University of Adelaide, Adelaide, Australia.
Peter-John WormaldDepartment of Surgery - Otolaryngology Head and Neck Surgery, University of Adelaide, Adelaide, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEpidural fibrosis is a common consequence of lumbar decompression surgery and has been implicated in the recurrence of radicular pain. Chitogel, combined with the iron-chelating agent deferiprone, has shown anti-fibrotic properties in preclinical models. This study aimed to evaluate the safety and feasibility of Chitogel–Deferiprone application in lumbar spinal surgery, marking its first human use in a sterile surgical site.

methodsThis single-arm, Phase I pilot study enrolled 20 patients undergoing lumbar decompression surgery. The Chitogel–Deferiprone hydrogel was applied to 30 operative levels at the time of wound closure. Safety was assessed via postoperative complication monitoring, particularly for wound infection. Secondary outcomes included patient-reported outcomes using the Lumbar Spine Outcomes Questionnaire (LSOQ) and MRI assessment of epidural fibrosis at 3 months. A composite fibrosis score and a binary “extensive scarring” classification were used to quantify scar burden. Paired t-tests, correlation analyses, and independent t-tests were used to evaluate symptom changes and relationships to fibrosis severity.

resultsNo deep wound infections or reoperations occurred during follow-up. One patient (5%) developed a superficial wound infection, consistent with expected postoperative complication rates. Of the 20 patients, 12 completed the 6-month LSOQ, showing significant improvements in back pain (42.4% reduction, p = 0.003), leg pain (49% reduction, p < 0.001), disability (34% reduction, p = 0.002), and physical symptoms (28.5% reduction, p = 0.037). MRI was completed in 14 patients (21 operative levels); 66% met Ross criteria for extensive scarring, although no correlation was found between fibrosis burden and symptom severity or improvement.

conclusionThis pilot study demonstrates that intraoperative application of Chitogel–Deferiprone in lumbar spine surgery is safe and feasible. Although improvements in symptoms were observed, no relationship between epidural fibrosis and postoperative pain was identified. These findings support the conduct of a larger, controlled trial to evaluate efficacy.

Indexed as

Decompression, SurgicalDeferiproneEpidural SpaceLumbar VertebraePostoperative ComplicationsPyridonesAdultAgedCicatrixFemaleFibrosisHumansMaleMiddle AgedPilot ProjectsTreatment OutcomeDeferipronePyridonesEpidural fibrosisFailed back surgery syndromeLumbar laminectomyLumbar microdiscectomy

Identifiers

PMID41272194

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.