NHS-POx-loaded patch versus fibrin sealant patch in a porcine robotic liver bleeding model.


Journal

BMC surgery
ISSN: 1471-2482
Titre abrégé: BMC Surg
Pays: England
ID NLM: 100968567

Informations de publication

Date de publication:
28 Aug 2023
Historique:
received: 18 04 2023
accepted: 18 08 2023
medline: 31 8 2023
pubmed: 29 8 2023
entrez: 28 8 2023
Statut: epublish

Résumé

The management of bleeding is paramount to any surgical procedure. With the increased use of less invasive laparoscopic and robotic methods, achieving hemostasis can be challenging since the surgeons cannot manually apply hemostatic agents directly onto bleeding tissue. In this study, we assessed the use of a pliable hemostatic sealant patch comprising fibrous gelatin carrier impregnated with poly(2-oxazoline) (NHS-POx) for hemostasis in robotic liver resection in a porcine bleeding model. The NHS-POx-loaded patch (GATT-Patch), was first evaluated in a Feasibility Study to treat surgical bleeding in 10 lesions, followed by a Comparative Study in which the NHS-POx patch was compared to a standard-of-care fibrin sealant patch (TachoSil), in 36 lesions (superficial, resection, or deep injuries mimicking metastasectomies). For each lesion type, the NHS-POx and fibrin sealant patches were used in an alternating fashion with 18 lesions treated with NHS-POx and 18 with the fibrin patch. Animal preparation and surgical procedures were consistent across studies. The primary outcome was time to hemostasis (TTH) within 3 min for the Feasibility Study and within 5 min for the Comparative Study. In the Feasibility Study, 8 of the 10 NHS-POx-treated lesions achieved hemostasis at 30 s and 3 min. In the Comparative Study, all 18 NHS-POx patch-treated lesions and 9 of the 18 fibrin sealant patch-treated lesions achieved hemostasis at 5 min. Median TTH with NHS-POx vs fibrin sealant patch was 30 vs 300 s (P < 0.001). In this animal study, hemostasis during robotic liver surgery was achieved faster and more often with the NHS-POx loaded vs fibrin sealant patch.

Sections du résumé

BACKGROUND BACKGROUND
The management of bleeding is paramount to any surgical procedure. With the increased use of less invasive laparoscopic and robotic methods, achieving hemostasis can be challenging since the surgeons cannot manually apply hemostatic agents directly onto bleeding tissue. In this study, we assessed the use of a pliable hemostatic sealant patch comprising fibrous gelatin carrier impregnated with poly(2-oxazoline) (NHS-POx) for hemostasis in robotic liver resection in a porcine bleeding model.
METHODS METHODS
The NHS-POx-loaded patch (GATT-Patch), was first evaluated in a Feasibility Study to treat surgical bleeding in 10 lesions, followed by a Comparative Study in which the NHS-POx patch was compared to a standard-of-care fibrin sealant patch (TachoSil), in 36 lesions (superficial, resection, or deep injuries mimicking metastasectomies). For each lesion type, the NHS-POx and fibrin sealant patches were used in an alternating fashion with 18 lesions treated with NHS-POx and 18 with the fibrin patch. Animal preparation and surgical procedures were consistent across studies. The primary outcome was time to hemostasis (TTH) within 3 min for the Feasibility Study and within 5 min for the Comparative Study.
RESULTS RESULTS
In the Feasibility Study, 8 of the 10 NHS-POx-treated lesions achieved hemostasis at 30 s and 3 min. In the Comparative Study, all 18 NHS-POx patch-treated lesions and 9 of the 18 fibrin sealant patch-treated lesions achieved hemostasis at 5 min. Median TTH with NHS-POx vs fibrin sealant patch was 30 vs 300 s (P < 0.001).
CONCLUSIONS CONCLUSIONS
In this animal study, hemostasis during robotic liver surgery was achieved faster and more often with the NHS-POx loaded vs fibrin sealant patch.

Identifiants

pubmed: 37641071
doi: 10.1186/s12893-023-02159-4
pii: 10.1186/s12893-023-02159-4
pmc: PMC10463878
doi:

Substances chimiques

Fibrin Tissue Adhesive 0
Hemostatics 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

257

Informations de copyright

© 2023. BioMed Central Ltd., part of Springer Nature.

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Auteurs

Mathieu D'Hondt (M)

Department of Digestive and Hepatobiliary/Pancreatic Surgery, AZ Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium. mathieudhondt2000@yahoo.com.

Edwin A Roozen (EA)

GATT Technologies, Nijmegen, The Netherlands.

Frederiek Nuytens (F)

Department of Digestive and Hepatobiliary/Pancreatic Surgery, AZ Groeninge Hospital, President Kennedylaan 4, 8500, Kortrijk, Belgium.

Johan Bender (J)

GATT Technologies, Nijmegen, The Netherlands.

Alexandre Mottrie (A)

ORSI Academy, Ghent (Melle), Belgium.

Kevin Bauwens (K)

ORSI Academy, Ghent (Melle), Belgium.

Stuart J Head (SJ)

GATT Technologies, Nijmegen, The Netherlands.

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Classifications MeSH