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

Primary Purpose

Fracture Fixation, Intra-Articular Fractures, Acetabulum

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitagel
Standard of care
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture Fixation focused on measuring Acetabulum, Fracture, Hemostatis, Vitagel, Fibrin sealant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitagel and Standard of Care

Standard of Care

Arm Description

This group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards 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.

Outcomes

Primary Outcome Measures

Intra-operative Rate of Blood Volume Loss
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.

Secondary Outcome Measures

Change in Hemoglobin Level
The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
Change in Hemoglobin Level
The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
Change in Hemoglobin Level
The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
Volume of Blood Products Transfused
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.
Units of Packed Red Blood Cells (pRBCs) Transfused
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.
Units of Fresh Frozen Plasma (FFP) Transfused
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.
Volume of Intra-operative Salvaged Blood Transfused
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.
Number of Participants With a Wound Complication
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).

Full Information

First Posted
October 18, 2010
Last Updated
November 20, 2018
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT01230931
Brief Title
Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)
Official Title
Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Study team left institution; no one remaining to finish study
Study Start Date
October 2010 (Actual)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Fixation, Intra-Articular Fractures, Acetabulum
Keywords
Acetabulum, Fracture, Hemostatis, Vitagel, Fibrin sealant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitagel and Standard of Care
Arm Type
Experimental
Arm Description
This group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vitagel
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard of care
Intervention Description
Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing.
Primary Outcome Measure Information:
Title
Intra-operative Rate of Blood Volume Loss
Description
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.
Time Frame
at the time of surgery
Secondary Outcome Measure Information:
Title
Change in Hemoglobin Level
Description
The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
Time Frame
baseline, post-operative day 1
Title
Change in Hemoglobin Level
Description
The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
Time Frame
baseline, post-operative day 2
Title
Change in Hemoglobin Level
Description
The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
Time Frame
baseline, post-operative day 3
Title
Volume of Blood Products Transfused
Description
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.
Time Frame
baseline through post-operative day 3
Title
Units of Packed Red Blood Cells (pRBCs) Transfused
Description
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.
Time Frame
baseline through post-operative day 3
Title
Units of Fresh Frozen Plasma (FFP) Transfused
Description
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.
Time Frame
baseline through post-operative day 3
Title
Volume of Intra-operative Salvaged Blood Transfused
Description
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.
Time Frame
baseline through post-operative day 3
Title
Number of Participants With a Wound Complication
Description
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).
Time Frame
at the time of discharge (about 2 weeks after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine G Ambrose, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19948697
Citation
Thoms RJ, Marwin SE. The role of fibrin sealants in orthopaedic surgery. J Am Acad Orthop Surg. 2009 Dec;17(12):727-36. doi: 10.5435/00124635-200912000-00001.
Results Reference
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16816947
Citation
Gardner MJ, Demetrakopoulos D, Klepchick PR, Mooar PA. The efficacy of autologous platelet gel in pain control and blood loss in total knee arthroplasty. An analysis of the haemoglobin, narcotic requirement and range of motion. Int Orthop. 2007 Jun;31(3):309-13. doi: 10.1007/s00264-006-0174-z. Epub 2006 Jul 1.
Results Reference
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PubMed Identifier
17972452
Citation
Zavadil DP, Satterlee CC, Costigan JM, Holt DW, Shostrom VK. Autologous platelet gel and platelet-poor plasma reduce pain with total shoulder arthroplasty. J Extra Corpor Technol. 2007 Sep;39(3):177-82.
Results Reference
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PubMed Identifier
16643230
Citation
Everts PA, Devilee RJ, Brown Mahoney C, Eeftinck-Schattenkerk M, Box HA, Knape JT, van Zundert A. Platelet gel and fibrin sealant reduce allogeneic blood transfusions in total knee arthroplasty. Acta Anaesthesiol Scand. 2006 May;50(5):593-9. doi: 10.1111/j.1399-6576.2006.001005.x.
Results Reference
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PubMed Identifier
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Citation
Horstmann WG, Slappendel R, van Hellemondt GG, Wymenga AW, Jack N, Everts PA. Autologous platelet gel in total knee arthroplasty: a prospective randomized study. Knee Surg Sports Traumatol Arthrosc. 2011 Jan;19(1):115-21. doi: 10.1007/s00167-010-1207-0. Epub 2010 Jul 18.
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11679600
Citation
Wang GJ, Hungerford DS, Savory CG, Rosenberg AG, Mont MA, Burks SG, Mayers SL, Spotnitz WD. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Surg Am. 2001 Oct;83(10):1503-5. doi: 10.2106/00004623-200110000-00007.
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PubMed Identifier
14649578
Citation
Wang GJ, Goldthwaite CA Jr, Burks S, Crawford R, Spotnitz WD; Orthopaedic Investigators Group. Fibrin sealant reduces perioperative blood loss in total hip replacement. J Long Term Eff Med Implants. 2003;13(5):399-411. doi: 10.1615/jlongtermeffmedimplants.v13.i5.50.
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PubMed Identifier
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Sherman R, Chapman WC, Hannon G, Block JE. Control of bone bleeding at the sternum and iliac crest donor sites using a collagen-based composite combined with autologous plasma: results of a randomized controlled trial. Orthopedics. 2001 Feb;24(2):137-41. doi: 10.3928/0147-7447-20010201-16.
Results Reference
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PubMed Identifier
10565650
Citation
Levy O, Martinowitz U, Oran A, Tauber C, Horoszowski H. The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study. J Bone Joint Surg Am. 1999 Nov;81(11):1580-8. doi: 10.2106/00004623-199911000-00010.
Results Reference
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Citation
Cillo JE Jr, Marx RE, Stevens MR. Evaluation of autologous platelet-poor plasma gel as a hemostatic adjunct after posterior iliac crest bone harvest. J Oral Maxillofac Surg. 2007 Sep;65(9):1734-8. doi: 10.1016/j.joms.2006.09.008.
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Citation
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Results Reference
background
Links:
URL
https://med.uth.edu/ortho/
Description
UT-Houston Department of Orthopaedic Surgery

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

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