Skip to main content
OpenTrials
Completed

NCT Number: NCT00658723

The Fibrin Patch Soft Tissue Study

The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemostasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects >= 18 years of age, requiring non-emergent, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures
  • Presence of an appropriate soft tissue Target Bleeding Site (TBS) as identified intraoperatively by the surgeon
  • Subjects must be willing to participate in the study, and provide written informed consent

Exclusion criteria

  • Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
  • Subject with TBS within an actively infected field
  • Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine
  • Subjects with known intolerance to blood products or to one of the components of the study product
  • Subjects unwilling to receive blood products
  • Subjects with 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

Treatment and study plan

Fibrin Pad

Drug

Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).

SURGICEL™

Device

Absorbable hemostat

Primary outcomes

  1. Proportion of Subjects Achieving Hemostatic Success

    Time frame: Intra-operative

    Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.

Secondary outcomes

  1. Proportion of Subjects Achieving Hemostatic Success

    Time frame: 10 minutes

    The proportion of subjects achieving hemostatic success at 10 minutes following randomization

  2. Incidence of Treatment Failures

    Time frame: Intra-operative

    If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure.

  3. Incidence of Adverse Events That Are Potentially Related to Bleeding

    Time frame: Intra-operative up to 1 month (+14 days)

    The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).

  4. Incidence of Adverse Events That Are Potentially Related to Thrombotic Events

    Time frame: Intra-operative up to 1 month (+14 days)

    The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism

  5. Incidence of Adverse Events Potentially Related to Transfusion Exposure

    Time frame: Intra-operative up to 1 month (+14 days)

    The types of events that were potentially related to transfusion exposure could have include hypocalcemia.

  6. Incidence of Re-treatment

    Time frame: Intra-operative

    The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period.

    In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment.

  7. Incidence of Adverse Events

    Time frame: 30 days (+14 days)

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Collaborators

  • OMRIX Biopharmaceuticals

Registry information

Official study title

A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 15, 2008
Registry last updated
Sep 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.