Clinical Trial: Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat

Brief Summary:

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

Detailed Summary:

Patients will be identified upon admission to Memorial Hermann-TMC, starting January 1, 2010, who fulfill the following inclusion criteria:

  1. Acetabular fracture deemed to require open reduction and internal fixation by one of the three principle attending surgeons.
  2. 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
  3. Ages 18-65
  4. Patient or family must consent to the research protocol

Potential study candidates will be excluded based on the following criteria

  1. Not meeting the aforementioned inclusion criteria
  2. Unstable hemoglobin levels for three days prior to acetabular surgery (i.e. no other bleeding sources)
  3. Revision surgery
  4. Surgery occurring more than two weeks post-injury
  5. History of blood dyscrasias or immunocompromised patients
  6. Patients with medical conditions requiring anticoagulation or INR above 1.5
  7. Obese patients (BMI >35)
  8. Known ongoing infection (local or systemic)
  9. Pregnant women

Consent Procedure: After admission, potential candidates will be recruited by either a resident, physician assistant, or nurse practitioner. The research protocol will be presented along wit
Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome: 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. ]

The amount of blood loss during the surgery as measured by cell saver and lap counts.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. ]
    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. ]

    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. ]
    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.


Original Secondary Outcome: Same as current

Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: October 18, 2010
Date Started: October 2010
Date Completion: July 2012
Last Updated: June 12, 2012
Last Verified: June 2012