Status:
TERMINATED
Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Fracture Fixation
Intra-Articular Fractures
Eligibility:
All Genders
18-65 years
Phase:
NA
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 aceta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01230931
Start Date
October 1 2010
End Date
April 1 2012
Last Update
December 11 2018
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030