Clinical trial NCT00307515: Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery
Official title: A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding During Retroperitoneal or Intra-Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Loss, Surgical
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
Collaborators: name: OMRIX Biopharmaceuticals
First posted: 2006-03-28
Enrollment: 135
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.

Detailed description: The time it will take to stop bleeding will be measured and compared between patients who are treated with fibrin sealant 2 to those who are treated with Surgicel®.

Eligibility criteria: Inclusion Criteria:

* Male and Female subjects requiring non-emergent retroperitoneal or intra-abdominal surgical procedures
* Presence of an appropriate soft-tissue target bleeding site (challenging bleeding site for which topical hemostatic adjuncts might typically be used) as identified intra-operatively by the surgeon
* Subjects must be willing to participate in the study and provide written informed consent

Exclusion Criteria:

* Subjects undergoing emergency surgery
* Parenchymal or anastomotic bleeding sites will not be considered for randomization
* Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
* Subjects with known intolerance to blood products or to one for the components of the study product
* Subjects unwilling to receive blood products
* Subjects with known autoimmune immunodeficiency diseases (including known HIV
* Subjects who are known, current alcohol and/or drug abusers
* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
* Female subjects who are pregnant or nursing

Primary outcomes:
measure: Hemostatic success within 10 minutes.
timeFrame: Intraoperative
Secondary outcomes:
measure: Absence of bleeding at pre-defined time points within 10 minutes
timeFrame: Intraoperative
measure: Incidence of treatment failures
timeFrame: Intraoperative
measure: Incidence of potential bleeding-related complications
timeFrame: 24 hr prior to discharge, Day 7-14
measure: Adverse events
timeFrame: Intraoperative, 24 hr prior to discharge, Day 7-14
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Baltimore
country: United States
facility: St. Agnes Healthcare, Inc.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Syracuse
country: United States
facility: GYN Oncology Associates
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
Study officials:
affiliation: Ethicon, Inc.
name: James Hart, MD
role: STUDY_DIRECTOR
References: