Hemostasis in Kocher-Langenbeck Approaches for Acetabular Surgery Using a Topical Surgical Hemostat
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Intra-operative Rate of Blood Volume Loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Vitagel and Standard of Care
This group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.
干预措施: Vitagel (Device)
Vitagel and Standard of Care
This group of patients will receive the vitagel topical surgical hemostat spray intra-operatively, along with all the other standards of care.
干预措施: Standard of care (Procedure)
Standard of Care
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.
干预措施: Standard of care (Procedure)
结局指标
主要结局
Intra-operative Rate of Blood Volume Loss
时间窗: at the time of surgery
The amount of blood loss during the surgery as measured by cell saver and lap counts. The cell saver and lap count totals will be summed.
次要结局
- Volume of Intra-operative Salvaged Blood Transfused(baseline through post-operative day 3)
- Number of Participants With a Wound Complication(at the time of discharge (about 2 weeks after surgery))
- Units of Packed Red Blood Cells (pRBCs) Transfused(baseline through post-operative day 3)
- Units of Fresh Frozen Plasma (FFP) Transfused(baseline through post-operative day 3)
- Volume of Blood Products Transfused(baseline through post-operative day 3)
- Change in Hemoglobin Level(baseline, post-operative day 3)
研究者
Catherine G. Ambrose
Associate Professor
The University of Texas Health Science Center, Houston