| 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. | | Posted | | Mean | Standard Deviation | milliliters per minute (mL/min) | | at the time of surgery | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0002.65± 1.43
- OG0013.63± 3.85
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| 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. | | Posted | | Mean | Standard Deviation | grams per deciliter (g/dL) | | baseline, post-operative day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | grams per deciliter (g/dL) | | baseline, post-operative day 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | grams per deciliter (g/dL) | | baseline, post-operative day 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | milliliters | | baseline through post-operative day 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | units | | baseline through post-operative day 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | units | | baseline through post-operative day 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | milliliters | | baseline through post-operative day 3 | | | | ID | Title | Description |
|---|
| OG000 | Vitagel and 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: 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. | | OG001 | 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. |
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| 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). | | Posted | | Count of Participants | | Participants | | at the time of discharge (about 2 weeks after surgery) | | | | ID | Title | Description |
|---|
| OG000 | Vitagel and 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: 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. | | OG001 | 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. |
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