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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
26
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.
Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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.
Time frame: at the time of surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: at the time of discharge (about 2 weeks after surgery)
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