Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)
Fractures of the acetabulum are considered rare in the general community, but are quite common in major metropolitan areas and tertiary care centers. These fractures are some of the most complex and challenging injuries to successfully treat in the orthopaedic field. Extensile surgical exposures are required to access this unique structure that comprises the cup of the hip joint. Large skin incisions, significant soft tissue dissection, and elevation of periosteum and muscle from the intact and fractured fragments are often required for anatomic reductions of the acetabulum and good outcomes. Thus, there are many sources of intra-operative bleeding that can sum up to require strategies aimed at preventing bleeding or replacing blood loss.
Cell-saver and transfusion of allogeneic blood products can replenish blood loss. The use of cell-saver is a good solution, but it is quite expensive. Trained perfusionists are required and cost over $400 per hour. Disposable products are also required for each patient. While blood loss can be great, often not enough blood is captured, processed, and available for return transfusion. Allogeneic blood transfusion is often routine. Appropriate blood is often on short supply. The cost of processing, testing, and transfusion is also high: minimum of $260 per standard unit of packed red blood cells. While risks of disease transmission are rare, they exist and can have serious consequences to patients. Transmission can include CMV (common), Hepatitis C (1:1,600,000), HIV (1:1,800,000), and bacteria (1:500,000). Transfusion reactions are more common and include febrile reactions (1:100), allergic reactions (1:100), hemolytic reactions (less common), and transfusion-related acute lung injury (1:5000).
Decreased operative times, aggressive electrocautery, ligation of identifiable vessels, minimal soft tissue dissection or stripping, topical agents such as gel foams, and thrombins are possible and available. But still, significant blood losses persist. Over the past decade, platelet gel products and fibrin sealants have been developed and provide another possible solution. There are some retrospective studies in the arthroplasty literature indicating these are good hemostatic agents. There is also some literature from the general, oral and maxillofacial, and spine surgical fields indicated these topical agents decrease intra-operative blood loss. But there are no large prospective, randomized studies in orthopedics, particularly traumatology, supporting the use of surgical hemostats.
This study protocol will use one surgical hemostat (Vitagel, Stryker). The study is a prospective, randomized controlled trial to evaluate this type of topical agent's role as a hemostatic agent in certain acetabular fracture types that require a non-extensile, posterior approach. Three fellowship-trained traumatologists will be involved: Drs. Milan Sen, Tim Achor, Josh Gary, Mark Prasarn, John Munz, and Andrew Burgess. Dr. Ambrose will assist in analyzing the data and statistical outcomes.
Purpose of Project. The purpose of our 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, a secondary endpoint will be incidence of wound dehiscence and/or infections.
The investigators primary hypothesis is the topical hemostat will result in lower blood losses intraoperatively and fewer units of perioperative blood product transfused.
Biological: Vitagel topical surgical hemostat
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat|
- Intra-operative blood loss [ Time Frame: The intra-operative blood will summed from the cell saver and lap count totals. This will be recorded on the data collection sheet prior to the patient leaving the operating room. ] [ Designated as safety issue: No ]The amount of blood loss during the surgery as measured by cell saver and lap counts.
- Change in hemoglobin level [ Time Frame: Hg levels will be monitored from the day of surgery to post-operative days 1,2, and 3. Change in Hg (from pre-op to post-op for each day) will be recorded on those specific days. There will be more data recorded after post-operative day 3. ] [ Designated as safety issue: No ]The amount change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, and three.
- Amount of blood products transfused. [ Time Frame: Number of blood products (pRBC and FFP) transfused in the first 3 post-op days will be recorded, as well as the amount of intra-operative salvaged blood transfused. After post-op day 3, no more data will be collected. ] [ Designated as safety issue: No ]
Number of blood products (pRBCs and FFP) will recorded throughout the operative day and post-op days 1,2, and 3.
If cell saver units are transfused, it will be recorded.
- Wound complications [ Time Frame: Wound complications will be recorded from the day of surgery for an average of two weeks post-operatively. Thereafter, there will be no data collected. ] [ Designated as safety issue: No ]The number of wound complications (dehiscence, infection) or the need to return to the operating to address a wound complication will be recorded. This study is an acute care study, so no data will be collected after the initial hospital stay.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
The group of patients will receive the vitagel spray intra-operatively, along with all the other standards of care.
Biological: Vitagel topical surgical hemostat
Vitagel is topical 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.
Other Name: Vitagel (Stryker)
No Intervention: No Vitagel
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.
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|Contact: William H Harvin, MDfirstname.lastname@example.org|
|Contact: Milan K Sen, MDemail@example.com|
|United States, Texas|
|Memorial Hermann Hospital-The Medical Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Bridget Solis, CCRP 713-704-4226 Bridget.Solis@memorialhermann.org|
|Contact: Erica Villegas 713-704-4214|
|Principal Investigator: William H Harvin, MD|
|Principal Investigator: Milan K Sen, MD|
|Sub-Investigator: Timothy Achor, MD|
|Sub-Investigator: Catherine Ambrose, MD|
|Principal Investigator:||William H Harvin, MD||Resident, Department of Orthopaedic Surgery, UTHSC-Houston|
|Study Chair:||Milan K Sen, MD||Associate Professor, Department of Orthopaedic Surgery, UTHSC-Houston|