The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of cases achieving hemostasis at 3 minutes after product application, and without re-bleeding up to 10 minutes after application.

A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery

Hemostasis

Hemostatic Techniques

Orthopaedics and surgery

ETHIZIA

SURGICEL Original

A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of ETHIZIA™ Versus SURGICEL® Original in Controlling Minimal, Mild, or Moderate Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic, Thoracic (Non-cardiac) and Extremity Surgery

Cases achieving hemostasis at 3 minutes following product application & with no rebleeding up to 10 minutes following application at the target bleeding site (first bleeding site treated) will be determined by Surface Bleeding Severity Scale (SBSS). SBSS provides a clinically validated score for assessment of bleeding at the target site, and consists of 6 scores (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, not immediately life-threatening, 5 = extreme, immediately life-threatening). A grade of 0 (None/Dry) on the SBSS is considered as achieving hemostasis.

Time to achieve hemostasis for target bleeding site up to 10 minutes will be evaluated and presented using Kaplan-Meier estimated distribution.

Percentage of bleeding sites achieving hemostasis at 3 minutes following product application & with no rebleeding up to 10 minutes following application at all bleeding sites (additional bleeding sites treated including target bleeding site) will be determined by SBSS. SBSS provides a clinically validated score for assessment of bleeding at the target site, and consists of 6 scores (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, not immediately life-threatening, 5 = extreme, immediately life-threatening).

Time to achieve hemostasis for all treated bleeding sites for up to 10 minutes will be evaluated.

Median time to hemostasis at target bleeding site will be reported.

Median time to hemostasis for all treated bleeding sites will be reported for both groups.

Treatment failure is defined as no hemostasis at 10 minutes or received rescue therapy prior to 10 minutes from the application of the study product.

Sustained hemostasis at all treated bleeding sites will be reported. Sustained hemostasis is defined as achieving hemostasis at 3 minutes with no rebleeding up to Day 28.

Proportion of bleeding sites with rebleeding after 10 minutes and prior to initiation of final fascia closure will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.

Percentage of bleeding sites achieving hemostasis with ETHIZIA or SURGICEL Original will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.

Proportion of bleeding sites requiring more than one application of randomized product in order to achieve hemostasis will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.

Proportion of bleeding sites that require a second surgical maneuver (for example, adjunct product, electrocautery, etcetera) as a rescue therapy to achieve hemostasis following treatment will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.

ETHIZIA will be applied at bleeding sites that meet the inclusion criteria in participants undergoing open surgery to control soft tissue bleeding. Participants will be followed up for 28 days after surgery.

SURGICEL Original will be applied at bleeding sites that meet the inclusion criteria in participants undergoing open surgery to control soft tissue bleeding. Participants will be followed-up for 28 days after surgery.

The objective of this clinical investigation is to evaluate the safety and efficacy of
ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery
when compared to SURGICEL Original in the percentage of cases achieving hemostasis at 3
minutes after product application, and without re-bleeding up to 10 minutes after
application.

Keck Hospital of USC

Washington University Barnes Jewish Hospital

Capital Health Medical Center - Hopewell

New York Presbyterian - Weill Cornell Medical Ctr

Intermountain Medical Center

UMC Radboud

Cases achieving hemostasis at 3 minutes following product application & with no
rebleeding at 10 minutes following application at the target bleeding site (first
bleeding site treated) will be determined by Surface Bleeding Severity Scale (SBSS). SBSS
provides a clinically validated score for assessment of bleeding at the target site, and
consists of 6 scores (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, not
immediately life-threatening, 5 = extreme, immediately life-threatening). A grade of 0
(None/Dry) on the SBSS is considered as achieving hemostasis.

Time to achieve hemostasis for target bleeding site up to 10 minutes will be evaluated
and presented using Kaplan-Meier estimated distribution.

Cases achieving hemostasis at 3 minutes following product application & with no
rebleeding at 10 minutes following application at all bleeding sites (additional bleeding
sites treated including target bleeding site) will be determined by SBSS. SBSS provides a
clinically validated score for assessment of bleeding at the target site, and consists of
6 scores (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, not immediately
life-threatening, 5 = extreme, immediately life-threatening). A grade of 0 (None/Dry) on
the SBSS is considered as achieving hemostasis.

Time to achieve hemostasis for all bleeding sites for up to 10 minutes will be evaluated
using Kaplan-Meier.

Median time to hemostasis for all treated bleeding sites will be reported for both
groups.

Treatment failure is defined as no hemostasis at 10 minutes. Participants that received
rescue treatment or experienced a rebleed between 3 minutes and 10 minutes will be
considered a treatment failure.

Percentage of treated bleeding sites with rebleeding after 10 minutes and prior to
initiation of final fascia closure will be reported.

Hemostasis is defined by a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale
(SBSS).

Proportion of treated bleeding sites requiring more than one application of randomized
product in order to achieve hemostasis will be reported.

Proportion of participants requiring more than one application of randomized product in
order to achieve hemostasis will be reported.

Proportion of treated bleeding sites that require a second surgical maneuver (e.g.
additional pressure, adjunct product, electrocautery, etc.) as a rescue treatment to
achieve hemostasis following treatment will be reported.

Proportion of participants who require a second surgical maneuver (e.g. additional
pressure, adjunct product, electrocautery, etc.) as a rescue treatment to achieve
hemostasis following treatment will be reported.

ETHIZIA will be applied at bleeding sites that meet the inclusion criteria in
participants undergoing open surgery to control soft tissue bleeding. Participants will
be followed up for 28 days after surgery.

SURGICEL Original will be applied at bleeding sites that meet the inclusion criteria in
participants undergoing open surgery to control soft tissue bleeding. Participants will
be followed-up for 28 days after surgery.

A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery

Trials at a glance

Trials at a glance

A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery

Outcome measures

Primary outcome measures

Secondary outcome measures