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

The University of Texas System (UT)

Status: Terminated

Conditions: Intra-Articular Fractures; Fracture Fixation; Acetabulum

Treatments: Procedure: Standard of care; Device: Vitagel

Study type: Interventional

Funder types: Other

Identifiers

NCT01230931

HSC-MS-09-0654

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Vitagel and Standard of Care

Experimental group

Description:

This group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.

Treatment:

Procedure: Standard of care

Device: Vitagel

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard of care