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

NCT01230931 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-12-11

Study results available
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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 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.

Conditions

  • Fracture Fixation
  • Intra-Articular Fractures
  • Acetabulum

Interventions

DEVICE

Vitagel

Vitagel (by Stryker) is a topical surgical hemostat spray that results in coagulation. The components are as follows: autogenous blood is drawn and centrifuged to produce a sample of platelets and growth factors; this is combined with a bovine thrombin and collagen solution. When the two are applied together, it produces the hemostatic effect.

PROCEDURE

Standard of care

Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Catherine G Ambrose, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-04-30
Completion
2012-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01230931 on ClinicalTrials.gov