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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fracture Fixation, Intra-Articular Fractures, Acetabulum

Intervention / Treatment
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* Device: Vitagel
* Procedure: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitagel and Standard of Care<br>This group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care. | Device: Vitagel<br>* 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.<br>Procedure: Standard of care<br>* Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing.<br>|
| Active Comparator: Standard of Care<br>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<br>* Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at the time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, post-operative day 1 | 
| 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. | baseline, post-operative day 2 | 
| 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. | baseline, post-operative day 3 | 
| 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. | baseline through post-operative day 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. | baseline through post-operative day 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. | baseline through post-operative day 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. | baseline through post-operative day 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). | at the time of discharge (about 2 weeks after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetabulum, Fracture, Hemostatis, Vitagel, Fibrin sealant