Oxidized Cellulose hEmostAsis evaluatioN

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to Surgicel® Original (Surgicel; in some countries marketed as Tabotamp®)

Official Title
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A Prospective, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Traumastem as an Adjunct to Hemostasis for Tissue Bleeding in Open Cardiac, Intra-abdominal (Including Retroperitoneal) and Pelvic Surgery

Conditions
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Intra-operative Bleeding

Intervention / Treatment
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* Device: Oxidized cellulose strip
* Device: Oxidized regenerated cellulose strip


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA AT SCREENING: Participants and/or legal representative has/have provided signed informed consent. An assent form should be signed by Participants less than 18 years of age, if possible; Participants undergoing planned (non-emergency) open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery; Participants of childbearing potential present with a negative serum pregnancy test, and agree to employ adequate birth control measures for the duration of the study. Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products; Participants are willing and able to comply with the requirements of the clinical investigation plan (CIP). INCLUSION CRITERIA INTRA-OPERATIVE: Soft tissue, vascular/anastomotic or parenchymal bleeding is present after primary surgical hemostasis has been achieved. The TBS is defined as intra-operative bleeding where conventional methods for achieving hemostasis are ineffective (based on the type of tissue) or impractical (based on the location) and where treatment with topical hemostatic adjuncts such as Traumastem is deemed appropriate for use. EXCLUSION CRITERIA: Emergency surgery; Transplantation surgery; Minimally invasive surgery; Neurological and ophthalmological surgery; Major arterial bleeding at the target bleeding site (TBS); Major intra-operative complications that require resuscitation or deviation from the planned surgical procedure; Severe local inflammation at the operating field; Any prior radiation therapy to the operating field; Known severe congenital or acquired immunodeficiency (eg, human immunodeficiency virus [HIV] infection or long-term [> 3 months] treatment with immunosuppressive drugs); Known hypersensitivity to components of the investigational device; Participant is pregnant or lactating at the time of enrollment or becomes pregnant prior to the planned surgery. If the participant becomes pregnant during the 30 days following treatment exposure, attempts will be made to follow her through completion of the pregnancy. The investigator will record a narrative description of the course of the pregnancy and its outcome; Participant has a clinically significant medical, psychiatric, or cognitive illness, or drug/alcohol abuse that, in the opinion of the investigator, would affect participant's safety or compliance; Participant has participated in another clinical study involving an investigational device/drug within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational device/drug during the course of this study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traumastem - oxidized cellulose strip<br> | Device: Oxidized cellulose strip<br>* Single use, intra-operative application to the target bleeding site<br>|
| Active Comparator: Surgicel® Original - oxidized regenerated cellulose strip<br> | Device: Oxidized regenerated cellulose strip<br>* A substance used to promote hemostasis (stops bleeding) based on oxidized regenerated cellulose<br>* Other names: Tabotamp®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events (AEs)/ adverse device effects (ADEs) | Occurrence of adverse events (AEs)/ adverse device effects (ADEs) up to 30 ± 5 days/ end-of-study visit after device application. | ≤30 ± 5 days/ end-of-study visit after device application |