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

Not Applicable

Terminated

Conditions: Intra-Articular Fractures
Fracture Fixation
Acetabulum

Interventions: Device: Vitagel
Procedure: Standard of care

Registration Number: NCT01230931

Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 26

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitagel and Standard of Care	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.
Vitagel and Standard of Care	Vitagel	This group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.
Standard of Care	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.

Primary Outcome Measures

Name	Time	Method
Intra-operative Rate of Blood Volume Loss	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.

Secondary Outcome Measures

Name	Time	Method
Volume of Blood Products Transfused	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.
Volume of Intra-operative Salvaged Blood Transfused	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.
Number of Participants With a Wound Complication	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).
Units of Packed Red Blood Cells (pRBCs) Transfused	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.
Units of Fresh Frozen Plasma (FFP) Transfused	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.
Change in Hemoglobin Level	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.