Trial Outcomes & Findings for Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel) (NCT NCT01230931)
NCT ID: NCT01230931
Last Updated: 2018-12-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
at the time of surgery
Results posted on
2018-12-11
Participant Flow
26 were enrolled, but only 20 were randomized.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)
Baseline characteristics by cohort
| Measure |
Vitagel and Standard of Care
n=10 Participants
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.
|
Standard of Care
n=10 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
36.4 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
33.8 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at the time of surgeryThe 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.
Outcome measures
| Measure |
Vitagel and Standard of Care
n=10 Participants
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.
|
Standard of Care
n=10 Participants
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.
|
|---|---|---|
|
Intra-operative Rate of Blood Volume Loss
|
2.65 milliliters per minute (mL/min)
Standard Deviation 1.43
|
3.63 milliliters per minute (mL/min)
Standard Deviation 3.85
|
SECONDARY outcome
Timeframe: baseline, post-operative day 1The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
Outcome measures
| Measure |
Vitagel and Standard of Care
n=10 Participants
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.
|
Standard of Care
n=10 Participants
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.
|
|---|---|---|
|
Change in Hemoglobin Level
|
-1.05 grams per deciliter (g/dL)
Standard Deviation 1.25
|
-1.16 grams per deciliter (g/dL)
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: baseline, post-operative day 2The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
Outcome measures
| Measure |
Vitagel and Standard of Care
n=10 Participants
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.
|
Standard of Care
n=10 Participants
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.
|
|---|---|---|
|
Change in Hemoglobin Level
|
-1.23 grams per deciliter (g/dL)
Standard Deviation 1.33
|
-1.41 grams per deciliter (g/dL)
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: baseline, post-operative day 3The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.
Outcome measures
| Measure |
Vitagel and Standard of Care
n=10 Participants
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.
|
Standard of Care
n=10 Participants
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.
|
|---|---|---|
|
Change in Hemoglobin Level
|
-1.12 grams per deciliter (g/dL)
Standard Deviation 1.60
|
-1.52 grams per deciliter (g/dL)
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: baseline through post-operative day 3The 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.
Outcome measures
| Measure |
Vitagel and Standard of Care
n=10 Participants
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.
|
Standard of Care
n=10 Participants
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.
|
|---|---|---|
|
Volume of Blood Products Transfused
|
455 milliliters
Standard Deviation 554
|
675 milliliters
Standard Deviation 1362
|
SECONDARY outcome
Timeframe: baseline through post-operative day 3The 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.
Outcome measures
| Measure |
Vitagel and Standard of Care
n=10 Participants
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.
|
Standard of Care
n=10 Participants
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.
|
|---|---|---|
|
Units of Packed Red Blood Cells (pRBCs) Transfused
|
0.8 units
Standard Deviation 1.3
|
1.0 units
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: baseline through post-operative day 3The 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.
Outcome measures
| Measure |
Vitagel and Standard of Care
n=10 Participants
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.
|
Standard of Care
n=10 Participants
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.
|
|---|---|---|
|
Units of Fresh Frozen Plasma (FFP) Transfused
|
0.10 units
Standard Deviation 0.32
|
0.40 units
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: baseline through post-operative day 3The 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.
Outcome measures
| Measure |
Vitagel and Standard of Care
n=10 Participants
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.
|
Standard of Care
n=10 Participants
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.
|
|---|---|---|
|
Volume of Intra-operative Salvaged Blood Transfused
|
175 milliliters
Standard Deviation 168.7
|
325 milliliters
Standard Deviation 697.7
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Vitagel and Standard of Care
n=10 Participants
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.
|
Standard of Care
n=10 Participants
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.
|
|---|---|---|
|
Number of Participants With a Wound Complication
|
1 Participants
|
1 Participants
|
Adverse Events
Vitagel and Standard of Care
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitagel and Standard of Care
n=10 participants at risk
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.
|
Standard of Care
n=10 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Wound Infection
|
0.00%
0/10 • Through the hospital stay (average length of stay was 11.5 days, range was 5-24 days)
The below-listed Adverse Events were not related to the intervention under study.
|
10.0%
1/10 • Number of events 1 • Through the hospital stay (average length of stay was 11.5 days, range was 5-24 days)
The below-listed Adverse Events were not related to the intervention under study.
|
|
Infections and infestations
Deep Wound Infection
|
10.0%
1/10 • Number of events 1 • Through the hospital stay (average length of stay was 11.5 days, range was 5-24 days)
The below-listed Adverse Events were not related to the intervention under study.
|
0.00%
0/10 • Through the hospital stay (average length of stay was 11.5 days, range was 5-24 days)
The below-listed Adverse Events were not related to the intervention under study.
|
|
Hepatobiliary disorders
Ischemic Hepatitis
|
10.0%
1/10 • Number of events 1 • Through the hospital stay (average length of stay was 11.5 days, range was 5-24 days)
The below-listed Adverse Events were not related to the intervention under study.
|
0.00%
0/10 • Through the hospital stay (average length of stay was 11.5 days, range was 5-24 days)
The below-listed Adverse Events were not related to the intervention under study.
|
Additional Information
Catherine G. Ambrose, PhD
The University of Texas Health Science Center at Houston
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place