Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)

November 20, 2018 updated by: Catherine G. Ambrose, The University of Texas Health Science Center, Houston

Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat

The purpose of the study is to determine whether surgical hemostats can minimize blood loss, need for allogeneic blood transfusions and their associated risks, and costs in patients with certain acetabular fractures requiring operative fixation via a non-extensile Kocher-Langenbeck surgical approach. Since surgical hemostats and other topical agents like platelet gel products have also been linked with improved wound healing, incidence of wound dehiscence and/or infections will also be examined. The investigators primary hypothesis is the topical hemostat will result in lower blood losses intraoperatively and fewer units of perioperative blood product transfused.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acetabular fracture deemed to require open reduction and internal fixation by one of the three principle attending surgeons.
  • Fixation must require a single non-extensile posterior approach (Kocher-Langenbeck)
  • Posterior wall, Posterior column, certain simple transverse and transverse associated with a posterior wall, T-type, and posterior wall-posterior column fracture types
  • Ages 18-65
  • Patient or family must consent to the research protocol

Exclusion Criteria:

  • Not meeting the aforementioned inclusion criteria
  • Unstable hemoglobin levels for three days prior to acetabular surgery (i.e. no other bleeding sources)
  • Revision surgery
  • Surgery occurring more than two weeks post-injury
  • History of blood dyscrasias or immunocompromised patients
  • Patients with medical conditions requiring anticoagulation or international normalized ratio (INR) above 1.5
  • Obese patients (BMI >35)
  • Known ongoing infection (local or systemic)
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitagel and Standard of Care
This group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.
Device: Vitagel
Vitagel (by Stryker) is a topical surgical hemostat spray that results in coagulation. The components are as follows: autogenous blood is drawn and centrifuged to produce a sample of platelets and growth factors; this is combined with a bovine thrombin and collagen solution. When the two are applied together, it produces the hemostatic effect.
Procedure: Standard of care
Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing.
Active Comparator: Standard of Care
This group of patients will receive the standard of care for hemostasis in acetabular surgery (electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing). They will not receive the vitagel product.
Procedure: Standard of care
Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-operative Rate of Blood Volume Loss
Time Frame: at the time of surgery
The amount of blood loss during the surgery as measured by cell saver and lap counts. The cell saver and lap count totals will be summed.
at the time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin Level
Time Frame: baseline, post-operative day 1
The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
baseline, post-operative day 1
Change in Hemoglobin Level
Time Frame: baseline, post-operative day 2
The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
baseline, post-operative day 2
Change in Hemoglobin Level
Time Frame: baseline, post-operative day 3
The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
baseline, post-operative day 3
Volume of Blood Products Transfused
Time Frame: baseline through post-operative day 3
The amount of blood products [packed red blood cells (pRBCs), fresh frozen plasma (FFP), intra-operative salvaged blood collected with a cell saver] transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3.
baseline through post-operative day 3
Units of Packed Red Blood Cells (pRBCs) Transfused
Time Frame: baseline through post-operative day 3
The amount of blood products [packed red blood cells (pRBCs), fresh frozen plasma (FFP), intra-operative salvaged blood collected with a cell saver] transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3.
baseline through post-operative day 3
Units of Fresh Frozen Plasma (FFP) Transfused
Time Frame: baseline through post-operative day 3
The amount of blood products (pRBCs and FFP) transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3. Intra-operative salvaged blood will be recovered with a cell saver, and if cell saver units are transfused, this will also be recorded on the operative day and on post-operative days 1, 2, and 3.
baseline through post-operative day 3
Volume of Intra-operative Salvaged Blood Transfused
Time Frame: baseline through post-operative day 3
The amount of blood products (pRBCs and FFP) transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3. Intra-operative salvaged blood will be recovered with a cell saver, and if cell saver units are transfused, this will also be recorded on the operative day and on post-operative days 1, 2, and 3.
baseline through post-operative day 3
Number of Participants With a Wound Complication
Time Frame: at the time of discharge (about 2 weeks after surgery)
The number of wound complications (dehiscence, infection) or the need to return to the operating to address a wound complication will be recorded. Wound complications will be recorded from the day of surgery until an average of two weeks post-operatively (this study is an acute care study, so no data will be collected after the initial hospital stay).
at the time of discharge (about 2 weeks after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Catherine G Ambrose, PhD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 28, 2010

First Posted (Estimate)

October 29, 2010

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-09-0654

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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