Acetabulum, Fracture Fixation, Intra-Articular Fractures
Conditions
Keywords
Acetabulum, Fracture, Hemostatis, Vitagel, Fibrin sealant
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.
Interventions
DEVICEVitagel
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.
PROCEDUREStandard of care
Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Change in Hemoglobin Level | 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. |
| 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 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. |
Countries
United States
Participant flow
Pre-assignment details
26 were enrolled, but only 20 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Vitagel and Standard of Care The group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.
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.
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. | 10 |
| 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.
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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Vitagel and Standard of Care | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 31.2 years STANDARD_DEVIATION 8.7 | 36.4 years STANDARD_DEVIATION 8.5 | 33.8 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment United States | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitagel and Standard of Care | Intra-operative Rate of Blood Volume Loss | 2.65 milliliters per minute (mL/min) | Standard Deviation 1.43 |
| Standard of Care | Intra-operative Rate of Blood Volume Loss | 3.63 milliliters per minute (mL/min) | Standard Deviation 3.85 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitagel and Standard of Care | Change in Hemoglobin Level | -1.12 grams per deciliter (g/dL) | Standard Deviation 1.6 |
| Standard of Care | Change in Hemoglobin Level | -1.52 grams per deciliter (g/dL) | Standard Deviation 1.86 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitagel and Standard of Care | Change in Hemoglobin Level | -1.05 grams per deciliter (g/dL) | Standard Deviation 1.25 |
| Standard of Care | Change in Hemoglobin Level | -1.16 grams per deciliter (g/dL) | Standard Deviation 1.46 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitagel and Standard of Care | Change in Hemoglobin Level | -1.23 grams per deciliter (g/dL) | Standard Deviation 1.33 |
| Standard of Care | Change in Hemoglobin Level | -1.41 grams per deciliter (g/dL) | Standard Deviation 1.72 |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vitagel and Standard of Care | Number of Participants With a Wound Complication | 1 Participants |
| Standard of Care | Number of Participants With a Wound Complication | 1 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitagel and Standard of Care | Units of Fresh Frozen Plasma (FFP) Transfused | 0.10 units | Standard Deviation 0.32 |
| Standard of Care | Units of Fresh Frozen Plasma (FFP) Transfused | 0.40 units | Standard Deviation 0.97 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitagel and Standard of Care | Units of Packed Red Blood Cells (pRBCs) Transfused | 0.8 units | Standard Deviation 1.3 |
| Standard of Care | Units of Packed Red Blood Cells (pRBCs) Transfused | 1.0 units | Standard Deviation 2.2 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitagel and Standard of Care | Volume of Blood Products Transfused | 455 milliliters | Standard Deviation 554 |
| Standard of Care | Volume of Blood Products Transfused | 675 milliliters | Standard Deviation 1362 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitagel and Standard of Care | Volume of Intra-operative Salvaged Blood Transfused | 175 milliliters | Standard Deviation 168.7 |
| Standard of Care | Volume of Intra-operative Salvaged Blood Transfused | 325 milliliters | Standard Deviation 697.7 |