Effectiveness of Hemopatch® versus Surgicel® Original to control mild and moderate liver bleeding.

Hemostasis Hemostat Hepatic bleeding Liver Patient safety Surgery Trauma VIBe SCALE Wound sealing

Journal

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

Informations de publication

Date de publication:
14 Aug 2022
Historique:
received: 28 01 2022
accepted: 18 07 2022
entrez: 14 8 2022
pubmed: 15 8 2022
medline: 17 8 2022
Statut: epublish

Résumé

Adjunct hemostats can be of use in certain surgical settings. We compared the effectiveness of two hemostats, Hemopatch® and Surgicel® Original in controlling bleeding from liver lesions in an experimental model. Control of grades 1 (mild) and 2 (moderate) bleeding (according to the Validated Intraoperative Bleeding [VIBe] SCALE) was assessed for 10 min after Hemopatch® (n = 198) or Surgicel® Original (n = 199) application on 397 liver surface lesions. The primary endpoint was hemostatic success (reaching VIBe SCALE grade 0 at 10 min). The secondary endpoint was time to hemostasis (time to reach and maintain grade 0). A generalized linear mixed model and an accelerated failure time model were used to assess the primary and secondary endpoints, respectively. The overall hemostatic success rate of Hemopatch® was statistically significantly superior to that of Surgicel® Original (83.8% versus 73.4%; p = 0.0036; odds ratio [OR] 2.38, 95% confidence interval [CI] 1.33-4.27) and time to hemostasis was reduced by 15.9% (p = 0.0032; 95% CI 0.749-0.944). Grade 2 bleeds treated with Hemopatch® had statistically significantly higher hemostatic success (71.7% versus 48.5%; p = 0.0007; OR 2.97, 95% CI 1.58-5.58) and shorter time to hemostasis (49.6% reduction, p = 3.6 × 10 Hemopatch® provided better control of VIBe SCALE bleeding compared to Surgicel® Original for Grade 2 bleeds in this porcine model, highlighting the importance of choosing a suitable hemostat to optimize control of bleeding during surgery.

Sections du résumé

BACKGROUND BACKGROUND
Adjunct hemostats can be of use in certain surgical settings. We compared the effectiveness of two hemostats, Hemopatch® and Surgicel® Original in controlling bleeding from liver lesions in an experimental model.
METHODS METHODS
Control of grades 1 (mild) and 2 (moderate) bleeding (according to the Validated Intraoperative Bleeding [VIBe] SCALE) was assessed for 10 min after Hemopatch® (n = 198) or Surgicel® Original (n = 199) application on 397 liver surface lesions. The primary endpoint was hemostatic success (reaching VIBe SCALE grade 0 at 10 min). The secondary endpoint was time to hemostasis (time to reach and maintain grade 0). A generalized linear mixed model and an accelerated failure time model were used to assess the primary and secondary endpoints, respectively.
RESULTS RESULTS
The overall hemostatic success rate of Hemopatch® was statistically significantly superior to that of Surgicel® Original (83.8% versus 73.4%; p = 0.0036; odds ratio [OR] 2.38, 95% confidence interval [CI] 1.33-4.27) and time to hemostasis was reduced by 15.9% (p = 0.0032; 95% CI 0.749-0.944). Grade 2 bleeds treated with Hemopatch® had statistically significantly higher hemostatic success (71.7% versus 48.5%; p = 0.0007; OR 2.97, 95% CI 1.58-5.58) and shorter time to hemostasis (49.6% reduction, p = 3.6 × 10
CONCLUSIONS CONCLUSIONS
Hemopatch® provided better control of VIBe SCALE bleeding compared to Surgicel® Original for Grade 2 bleeds in this porcine model, highlighting the importance of choosing a suitable hemostat to optimize control of bleeding during surgery.

Identifiants

pubmed: 35965336
doi: 10.1186/s12893-022-01747-0
pii: 10.1186/s12893-022-01747-0
pmc: PMC9375927
doi:

Substances chimiques

Cellulose, Oxidized 0
Hemostatics 0
Surgicel 82347-53-3

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

316

Informations de copyright

© 2022. The Author(s).

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Auteurs

Selman Uranues (S)

Section for Surgical Research, Department of Surgery, Medical University of Graz, Graz, Austria. selman.uranues@medunigraz.at.
Section for Surgical Research, Medical University of Graz, Auenbruggerplatz 29, 8036, Graz, Austria. selman.uranues@medunigraz.at.

Abraham Fingerhut (A)

Section for Surgical Research, Department of Surgery, Medical University of Graz, Graz, Austria.

Eve Levin (E)

Baxter Healthcare Corporation, Deerfield, IL, USA.

Daniel Spazierer (D)

Baxter Medical Products GmbH, Vienna, Austria.

Nastaran Rahimi (N)

Baxter Medical Products GmbH, Vienna, Austria.

Bernhard Baumgartner (B)

Baxter Healthcare Corporation, Deerfield, IL, USA.

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Classifications MeSH