Adhesions, infl ammatory response and foreign body giant cells infi ltration of the topical hemostats TachoSil®, Hemopatch™ and Veriset™ – An Animal Study

Nissen, Line Schiøtt; Hunter, Jacob B.; Rütz, Kenneth; Bollen, Peter

doi:10.17352/2455-2968.000043

Cited by 8 publications

(3 citation statements)

References 18 publications

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“…Despite the benefits of fibrinogen-thrombin-impregnated collagen patches shown in this study, along with the reduction in the risk of bleeding, most hemostatic agents can induce temporary inflammatory reactions and cause adhesions [52,53]. The application of a fibrin patch can significantly impede the identification and dissection of the facial nerve or remaining tissue when revision surgery is required, and appropriate care should be taken when there is a possibility of revision surgery.…”

Section: Discussionmentioning

confidence: 83%

Effectiveness of the Fibrinogen-Thrombin-Impregnated Collagen Patch in the Prevention of Postoperative Complications after Parotidectomy: A Single-Blinded, Randomized Controlled Study

Song

Won

et al. 2022

JCM

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We investigated whether a fibrinogen-thrombin collagen sponge patch reduces postoperative complications of parotid gland surgery. This single-blinded, randomized controlled study included 165 patients who underwent parotid surgery for benign tumors (2018–2019) at a tertiary center. Primary outcomes were postoperative drain amount, days until drain removal, and discharge. Patients were scheduled for follow-up at 1 and 4 weeks, and 3 months after surgery. Complications including surgical site infection, pain, seroma, sialocele, salivary fistula, facial nerve palsy, Frey’s syndrome with subjective symptoms, and facial asymmetry were analyzed. After identifying confounding variables, multivariate approaches were used. Histologic analysis was performed in a mouse model of salivary gland surgery. In total, 162 patients (77, fibrinogen-thrombin collagen patch group; 85, controls) were included, with no significant between-group differences other than resected tissue. Among postoperative total drain amount and days until drain removal and discharge, the only postoperative total drain was significantly lower in the patch group than in the control group in the adjusted model. Additionally, although validation through robust trials with longer follow-up is needed, we found the potential benefit of the fibrinogen patch on Frey’s syndrome and facial asymmetry. In conclusion, fibrinogen-thrombin-impregnated collagen patches in parotidectomy can reduce postoperative drainage and improve outcomes.

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Section: Discussionmentioning

confidence: 83%

Effectiveness of the Fibrinogen-Thrombin-Impregnated Collagen Patch in the Prevention of Postoperative Complications after Parotidectomy: A Single-Blinded, Randomized Controlled Study

Song

Won

et al. 2022

JCM

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“…The almost 100 percent of animals with adhesions at the patch localizations at all time points could be considered a serious related adverse event. However, we cannot rule out that adhesions were due to the surgical procedure and bleeding from injuries, as is expected with major abdominal surgery irrespective of applying hemostatic patches (31,32).…”

Section: Methodsmentioning

confidence: 95%

Efficacy of a novel polyoxazoline based hemostatic patch in liver and spleen surgery

Roozen

Lomme

Calon

et al. 2023

Preprint

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BACKGROUND: A new hemostatic sealant based on a N-hydroxy-succinimide polyoxazoline (NHS-POx) polymer was evaluated to determine hemostatic efficacy and long-term wound healing and adverse effects in a large animal model of parenchymal organ surgical bleeds. METHODS: Experiment 1 included 20 pigs that were treated with two NHS-POx patch prototypes (a gelatin fibrous carrier (GFC) with NHS-POx and an oxidized regenerated cellulose (ORC) with poly(lactic-co-glycolic acid)-NHS-POx:NU-POx (nucleophilically activated polyoxazoline)), a blank gelatin patch (GFC-Blank), TachoSil®, and Veriset™ to stop moderate liver and spleen punch bleedings. After various survival periods (1-6 weeks), pigs were re-operated to evaluate patch degradation and parenchymal healing. During the re-operation experiment 2 was performed; partial liver and spleen resections with severe bleeding, and hemostatic efficacy was evaluated under normal and heparinized conditions of the two previous prototypes and one additional NHS-POx patch. In the third experiment an improved NHS-POx patch (GATT-Patch; GFC-NHS-POx and added 20% as nucleophilically activated polyoxazoline; NU-POx) was compared with TachoSil®, Veriset™ and GFC-Blank on punch bleedings and partial liver and spleen resections for rapid (10 seconds) hemostatic efficacy. RESULTS: NHS-POx-based patches showed better (GFC-NHS-POx 83.1 %, ORC-PLGA-NHS-POx: NU-POx 98.3%) hemostatic efficacy compared to TachoSil® (25.0%) and GFC blank (43.3%), and comparable efficacy with Veriset™ (96.7%) on moderate standardized punch bleedings on liver and spleen. All patches demonstrated gradual degradation over 6 weeks with a reduced local inflammation rate and an improved wound healing. For severe bleedings under non-heparinized conditions, hemostasis was achieved in 100% for Veriset™, 40% for TachoSil, and 80-100% for the three NHS-POx prototypes; similar differences between patches remained for heparinized conditions. In experiment 3, GATT-Patch, Veriset™, TachoSil and GFC-Blank reached hemostasis after 10 seconds in 100%, 42.8%, 7.1% and 14.3% respectively, and at 3 minutes in 100%, 100%, 14.3% and 35.7% respectively, on all liver and spleen punctures and resections. CONCLUSIONS: NHS-POx-based patches, and particularly the GATT-Patch, are fast in achieving effective hemostatic sealing on standardized moderate and severe bleedings without apparent long term adverse events.

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“…While there are several topical hemostatic formulations available for clinical use, such as FloSeal, QuikClot, XSTAT, ChitoFlex, HemCon, ResQFoam, TachoSil, and Hemopatch, − some of these products have limitations, including easy disintegration, allergic reactions, and exothermic reactions upon application. − Therefore, there is a need to develop an optimal hemostatic technology that can stop bleeding in challenging clinical settings.…”

Section: Introductionmentioning

confidence: 99%

Nanoapatite-Loaded κ-Carrageenan/Poly(vinyl alcohol)-Based Injectable Cryogel for Hemostasis and Wound Healing

Kumar,

Bose,

Kumar

et al. 2024

Biomacromolecules

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Immediate control of excessive bleeding and prevention of infections are of utmost importance in the management of wounds. Cryogels have emerged as promising materials for the rapid release of medication and achieving hemostasis. However, their quick release properties pose the challenge of exposing patients to high concentrations of drugs. In this study, hybrid nanocomposites were developed to address this issue by combining poly(vinyl alcohol) and κ-carrageenan with whitlockite nanoapatite (WNA) particles and ciprofloxacin, aiming to achieve rapid hemostasis and sustained antibacterial effects. A physically cross-linked cryogel was obtained by subjecting a blend of poly(vinyl alcohol) and κ-carrageenan to successive freezing−thawing cycles, followed by the addition of WNA. Furthermore, ciprofloxacin was introduced into the cryogel matrix for subsequent evaluation of its wound healing properties. The resulting gel system exhibited a 3D microporous structure and demonstrated excellent swelling, low cytotoxicity, and outstanding mechanical properties. These characteristics were evaluated through analytical and rheological experiments. The nanocomposite cryogel with 4% whitlockite showed extended drug release of 71.21 ± 3.5% over 21 days and antibacterial activity with a considerable growth inhibition zone (4.19 ± 3.55 cm). Experiments on a rat model demonstrated a rapid hemostasis property of cryogels within an average of 83 ± 4 s and accelerated the process of wound healing with 96.34% contraction compared to the standard, which exhibited only ∼78% after 14 days. The histopathological analysis revealed that the process of epidermal re-epithelialization took around 14 days following the skin incision. The cryogel loaded with WNAs and ciprofloxacin holds great potential for strategic utilization in wound management applications as an effective material for hemostasis and anti-infection purposes.

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Adhesions, infl ammatory response and foreign body giant cells infi ltration of the topical hemostats TachoSil®, Hemopatch™ and Veriset™ – An Animal Study

Cited by 8 publications

References 18 publications

Effectiveness of the Fibrinogen-Thrombin-Impregnated Collagen Patch in the Prevention of Postoperative Complications after Parotidectomy: A Single-Blinded, Randomized Controlled Study

Effectiveness of the Fibrinogen-Thrombin-Impregnated Collagen Patch in the Prevention of Postoperative Complications after Parotidectomy: A Single-Blinded, Randomized Controlled Study

Efficacy of a novel polyoxazoline based hemostatic patch in liver and spleen surgery

Nanoapatite-Loaded κ-Carrageenan/Poly(vinyl alcohol)-Based Injectable Cryogel for Hemostasis and Wound Healing

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