Prevention of peridural adhesions in spinal surgery: Assessing safety and efficacy of Chitogel with Deferiprone in a sheep model

Sundaresan, Rajan; Mascarenhas, Annika; Nguyen-Hoang, Ann; Fong, Stephanie; Jukes, Alistair; Richter, Katharina; Bassiouni, Ahmed; Patel, Sandy; Chryssidis, Steve; Otto, Sophia; Moratti, Stephen C.; Psaltis, Alkis James; Vreugde, Sarah; Wormald, Peter‐John

doi:10.1016/j.jocn.2019.12.042

Cited by 8 publications

(7 citation statements)

References 31 publications

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“…16,22 Although both of these agents were shown to have good safety and tolerability profiles, little additional benefit was seen in ostial preservation. A larger sample size is needed to comprehensively assess possible benefits with lower doses used in subsequent studies with good effect 26,27 in terms of preservation of ostial size, mucosal healing and antibacterial effects.…”

Section: Discussionmentioning

confidence: 99%

Wound healing in endoscopic sinus surgery: Phase 1 clinical trial evaluating the role of Chitogel with adjuvants

Sundaresan

Bennett

Cooksley

et al. 2022

Clinical Otolaryngology

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Objectives: This study aimed to determine the safety and efficacy of Chitogel, with and without Deferiprone (Def) and Gallium Protoporphyrin (GaPP), as a promoter of wound healing to improve surgical outcomes after endoscopic sinus susgery. Design: A double-blinded, randomised control human clinical trial was conducted in patients undergoing ESS as a treatment for chronic rhinosinusitis. Participants underwent functional ESS or FESS with drill out as required and were randomised to receive test product Chitogel, Chitogel in combination with Def or Def-GaPP versus no packing (control). Setting: Ostial stenosis and persistent inflammation are the main reasons for revision endoscopic sinus surgery (ESS). Post-operative (PO) dressings can improve PO wound healing and patient outcomes after ESS. Participants: Eighty two patients were included in this study with 79 patients completing the study with 40 undergoing full house FESS and 39 FESS plus frontal drillout.Main Outcome Measures: Patients were followed up at 2, 6 and 12 weeks PO, and outcome scores such as SNOT-22, VAS and LKS, pre and post-surgery (12 weeks) were compared.Results: Seventy nine patients completed the study, there was a significant reduction in SNOT-22 score and improvement of VAS at 12 weeks in patients treated with Chitogel compared to control (p < .05). In those patients, the mean ostium area for the Chitogel and the Chitogel + Def + GaPP groups was higher across all three sinuses compared to the no-treatment control group, without statistical significance.Sphenoid sinus ostium was significantly more patent in patients treated with Chitogel compared to the control at the 12-week time point (p < .05). Conclusion:Chitogel as a PO dressing after ESS results in the best patient-reported symptom scores and objective measurements. The combination of Def and GaPP to Chitogel though proving safe, had no effect on the ostium patency or mucosal healing.

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Section: Discussionmentioning

confidence: 99%

Wound healing in endoscopic sinus surgery: Phase 1 clinical trial evaluating the role of Chitogel with adjuvants

Sundaresan

Bennett

Cooksley

et al. 2022

Clinical Otolaryngology

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“…The rate of postoperative FBSS in those undergoing lumbar laminectomy is approximately 8–40% and this leads to re-operation and adhesion release in about 4–9% of the patients [ 12 , 13 ]. The main cause of the FBSS is considered to adhesion formation between the paravertebral muscles and the dura matter which extends into the intervertebral foramina and leads to neural compression and clinical symptoms of LBP and radiculopathy [ 19 ]. The stages of adhesion formation could be classified as local inflammatory response (3–5 days after surgery), fibroblast proliferation and collagen deposition (2–3 weeks after surgery), and reconstruction and remodeling of the fibrillary connective tissue (months to years) [ 30 , 31 ].…”

Section: Discussionmentioning

confidence: 99%

“…The stages of adhesion formation could be classified as local inflammatory response (3–5 days after surgery), fibroblast proliferation and collagen deposition (2–3 weeks after surgery), and reconstruction and remodeling of the fibrillary connective tissue (months to years) [ 30 , 31 ]. Postoperative hemorrhage and blood deposition on the dura is also among important factors of postoperative adhesions for which a hemovac is usually inserted and kept for 24-hour [ 19 ]. FBSS is multifactorial and thus the treatment should be based on the pathophysiology.…”

Section: Discussionmentioning

confidence: 99%

“…The adhesion barrier gels are composed of biomaterials with large molecular weight, extensive biological function and complexity in structure [ 32 ]. These biomaterials have been tested in animal studies with promising results [ 19 ]. However, their clinical value in standard randomized clinical trials (RTCs) have been tested in limited studies with controversial results [ 17 , 18 , 21 , 22 , 23 , 25 , 26 , 27 , 28 , 29 ].…”

Section: Discussionmentioning

confidence: 99%

“…Several approaches and interventions have been introduced and examined to decrease the rate of FBSS, recurrent disc herniation and radiculopathy following lumbar laminectomy which include minimal invasive techniques [ 14 ], medical therapies [ 15 ], application of biomaterials [ 16 ] and intraoperative use of adhesive barrier gels [ 17 , 18 ]; however, the results are controversial. Among these approaches, a great interest has been paid to intraoperative application of biomaterials that refer to absorbable anti-adhesive barrier gels [ 19 , 20 ]. Several products have been introduced by now which are cellulose-based and follow the same instruction of use and the same mechanism of action: to provide a barrier gel between the dura matter and the paravertebral muscles and in return, preventing adhesion between these issues and avoiding secondary compression of the neural elements [ 20 ].…”

Section: Introductionmentioning

confidence: 99%

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Effects of adhesion barrier gel on functional outcomes of patients with lumbar disc herniation surgery; A systematic review and meta-analysis of clinical trials

Hosseini

Niakan

Dehghankhalili

et al. 2021

Heliyon

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Failed Back Surgery Syndrome (FBSS) is persistent pain and disability following lumbar laminectomy which is associated with decreased quality of life and disability and has been reported in up to 40% of the patients undergoing lumbar laminectomy. Several approaches have been introduced to reduce the rate of the FBSS. Among these, applying anti-adhesive barrier gels have been studied with interest with controversial results. The aim of the current study was to determine the effects of anti-adhesive barrier gels on functional outcome and recurrence of patients undergoing lumbar disc surgery. We searched databases including EMBASE, PUBMED, Web of Science, Scopus, Cochrane Library, and scholar databases until November 2019. To assess the heterogeneity across included studies was used Cochran's Q and I-square (I 2 ) statistics. Standardized mean difference (SMD) and 95% CI between were used to estimate pooled effect sizes. Out of 4507, 10 clinical trials found to be appropriate for current meta-analysis. The pooled results of included clinical trials indicated that adhesion barrier gel significantly decreased leg pain (LP) (SMD ¼ À0.31; 95% CI, À0.60, À0.03; P ¼ 0.032; I 2 : 59.2%) among patients with lumbar disc herniation surgery. Back pain (BP) (SMD ¼ À0.03; 95% CI, À0.23, 0.16; P ¼ 0.734; I 2 : 40.2%), and Oswestry disability index (ODI) (SMD ¼ À0.11; 95% CI, À0.27, 0.05; P ¼ 0.178; I 2 : 0.0%), were not significantly affected following adhesion barrier gel application. Application of adhesion barrier gel in single level lumbar disc surgery is associated with deceased leg pain. However, its application does not affect the low back pain, disability and gate. Further, larger randomized clinical trials are required.

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Deferiprone and Gallium-Protoporphyrin Chitogel as an antimicrobial treatment: Preclinical studies demonstrating antimicrobial activity for S. aureus infected cutaneous wounds

Kennewell,

Haidari,

Mashtoub

et al. 2024

International Journal of Biological Macromolecules

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Prevention of peridural adhesions in spinal surgery: Assessing safety and efficacy of Chitogel with Deferiprone in a sheep model

Cited by 8 publications

References 31 publications

Wound healing in endoscopic sinus surgery: Phase 1 clinical trial evaluating the role of Chitogel with adjuvants

Wound healing in endoscopic sinus surgery: Phase 1 clinical trial evaluating the role of Chitogel with adjuvants

Effects of adhesion barrier gel on functional outcomes of patients with lumbar disc herniation surgery; A systematic review and meta-analysis of clinical trials

Deferiprone and Gallium-Protoporphyrin Chitogel as an antimicrobial treatment: Preclinical studies demonstrating antimicrobial activity for S. aureus infected cutaneous wounds

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