Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat (Vitagel)
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/13/2018 |
| Start Date: | October 2010 |
| End Date: | April 2012 |
Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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