Oxidized Cellulose hEmostAsis evaluatioN

Not Applicable

Completed

• Conditions: Intra-operative Bleeding
• Interventions: Device: Oxidized cellulose strip; Device: Oxidized regenerated cellulose strip

• Registration Number: NCT01637025
• Lead Sponsor: Baxter Healthcare Corporation

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®)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traumastem - oxidized cellulose strip	Oxidized cellulose strip	-
Surgicel® Original - oxidized regenerated cellulose strip	Oxidized regenerated cellulose strip	-

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events (AEs)/ adverse device effects (ADEs)	≤30 ± 5 days/ end-of-study visit after device application	Occurrence of adverse events (AEs)/ adverse device effects (ADEs) up to 30 ± 5 days/ end-of-study visit after device application.

Trial Locations

Locations (23)

Department of Surgery Albert Szentgyörgyi Clinical Center; 🇭🇺 Szeged, Hungary

Chirurgicke oddeleni Fakultni nemocnice Na Bulovce; 🇨🇿 Praha, Czech Republic

I. Surgery Clinic Semmelweis Egyetem Általános Orvostudományi Kar; 🇭🇺 Budapest, Hungary

Chirurgicke oddeleni Nemocnice Liberec; 🇨🇿 Liberec, Czech Republic

Kardiochirurgicke oddeleni FN Plzen; 🇨🇿 Plzen - Lochotin, Czech Republic

Chirurgicka klinika FN KV; 🇨🇿 Praha, Czech Republic

Chirurgicka klinika UVN; 🇨🇿 Praha, Czech Republic

Kardiochirurgicka klinika FN KV; 🇨🇿 Praha, Czech Republic

Klinika kardiovaskularni chirurgie IKEM; 🇨🇿 Praha, Czech Republic

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

Department of General Surgery Petz Aladár Megyei Oktató Kórház; 🇭🇺 Gyor, Hungary

Gynaecology and Obstetrics Petz Aldor Country Teaching Hospital; 🇭🇺 Gyor, Hungary

Department of General Surgery Békés Megyei Képviselotestület Pándy Kálmán Kórház; 🇭🇺 Szekesfehervar, 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 Ogólnej, Gastroenterologicznej i Endokrynologicznej, Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu; 🇵🇱 Wrocław, Poland

Klinika Chirurgii Naczyniowej, Instytut Hematologii I Transfuzjologii,; 🇵🇱 Warszawa, Poland

Klinik für Allgemein-, Visceral- und Transplantationschirurgie Charité Berlin; 🇩🇪 Berlin, Germany

Allgemein- und Viszeralchirurgie Johann Wolfgang Goethe Universitätsklinikum; 🇩🇪 Frankfurt am Main, Germany