Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)
Stopped early · Not applicable
Conditions studied: Fracture Fixation, Intra-Articular Fractures, Acetabulum
In brief
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 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, incidence of wound dehiscence and/or infections will also be examined. The investigators primary hypothesis is the topical hemostat will result in lower blood losses intraoperatively and fewer units of perioperative blood product transfused.
Key facts
- Study ID
- NCT01230931
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 26
- Starts
- 2010-10-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2018-12-11
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The University of Texas Health Science Center at Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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