Oxidized Cellulose hEmostAsis evaluatioN

NCT ID: NCT01637025

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-11-30

Brief Summary

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®)

Conditions

Intra-operative Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traumastem - oxidized cellulose strip

Group Type: EXPERIMENTAL

Oxidized cellulose strip

Intervention Type: DEVICE

Single use, intra-operative application to the target bleeding site

Surgicel® Original - oxidized regenerated cellulose strip

Group Type: ACTIVE_COMPARATOR

Oxidized regenerated cellulose strip

Intervention Type: DEVICE

A substance used to promote hemostasis (stops bleeding) based on oxidized regenerated cellulose

Interventions

Oxidized cellulose strip

Single use, intra-operative application to the target bleeding site

Intervention Type: DEVICE

Oxidized regenerated cellulose strip

A substance used to promote hemostasis (stops bleeding) based on oxidized regenerated cellulose

Intervention Type: DEVICE

Other Intervention Names

Tabotamp®

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Participants undergoing planned (non-emergency) open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery;

3. 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;

4. Participants are willing and able to comply with the requirements of the clinical investigation plan (CIP).

5. 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

1. Emergency surgery;

2. Transplantation surgery;

3. Minimally invasive surgery;

4. Neurological and ophthalmological surgery;

5. Major arterial bleeding at the target bleeding site (TBS);

6. Major intra-operative complications that require resuscitation or deviation from the planned surgical procedure;

7. Severe local inflammation at the operating field;

8. Any prior radiation therapy to the operating field;

9. Known severe congenital or acquired immunodeficiency (eg, human immunodeficiency virus [HIV] infection or long-term [> 3 months] treatment with immunosuppressive drugs);

10. Known hypersensitivity to components of the investigational device;

11. 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;

12. 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;

13. 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Innovations GmbH

INDUSTRY

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edith Hantak, DVM

Role: STUDY_DIRECTOR

Baxter Innovations GmbH

Locations

Chirurgicke oddeleni Nemocnice Liberec

Liberec, , Czechia

Kardiochirurgicke oddeleni FN Plzen

Plzen - Lochotin, , Czechia

Chirurgicka klinika FN KV

Prague, , Czechia

Chirurgicka klinika UVN

Prague, , Czechia

Chirurgicke oddeleni Fakultni nemocnice Na Bulovce

Prague, , Czechia

Kardiochirurgicka klinika FN KV

Prague, , Czechia

Klinika kardiovaskularni chirurgie IKEM

Prague, , Czechia

Klinik für Allgemein-, Visceral- und Transplantationschirurgie Charité Berlin

Berlin, , Germany

Klinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurguie Charité Universitätsmedizin Berlin - Campus Mitte

Berlin, , Germany

Allgemein- und Viszeralchirurgie Johann Wolfgang Goethe Universitätsklinikum

Frankfurt am Main, , Germany

Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie Universitätsklinikum des Saarlandes

Homburg/Saar, , Germany

Klinik für Allgemein- und Viszeralchirurgie Klinikum Magdeburg

Magdeburg, , Germany

Klinik und Poliklinik für Allgemein- und Abdominalchirurgie Universitätsmedizin Mainz

Mainz, , Germany

I. Surgery Clinic Semmelweis Egyetem Általános Orvostudományi Kar

Budapest, , Hungary

Department of General Surgery Petz Aladár Megyei Oktató Kórház

Győr, , Hungary

Gynaecology and Obstetrics Petz Aldor Country Teaching Hospital

Győr, , Hungary

Department of General Surgery Békés Megyei Képviselotestület Pándy Kálmán Kórház

Gyula, , Hungary

Department of Surgery Albert Szentgyörgyi Clinical Center

Szeged, , Hungary

Department of General Surgery Békés Megyei Képviselotestület Pándy Kálmán Kórház

Székesfehérvár, , Hungary

Klinika Chirurgii Naczyniowej, Ogólnej i Angiologii, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM,

Szczecin, , Poland

Klinika Chirurgii Ogólnej i Translantacyjnej, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM,

Szczecin, , Poland

Niepubliczny Specjalistyczny Zakład Opieki Zdrowotnej "MEDICUS",

Środa Wielkopolska, , Poland

Klinika Chirurgii Naczyniowej, Instytut Hematologii I Transfuzjologii,

Warsaw, , Poland

Klinika Chirurgii Ogólnej, Gastroenterologicznej i Endokrynologicznej, Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu

Wroclaw, , Poland

Countries

Czechia; Germany; Hungary; Poland

Other Identifiers

621101

Identifier Type: -

Identifier Source: org_study_id