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

NCT01230931 | Terminated Results FDA Device

• 1 other identifier: HSC-MS-09-0654
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acetabulum; Fracture; Hemostatis; Vitagel; Fibrin sealant

Outcome Measures

Primary Outcomes (1)

• Intra-operative Rate of Blood Volume Loss

  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.

  at the time of surgery

Secondary Outcomes (8)

• Change in Hemoglobin Level

  baseline, post-operative day 1

• Change in Hemoglobin Level

  baseline, post-operative day 2

• Change in Hemoglobin Level

  baseline, post-operative day 3

• Volume of Blood Products Transfused

  baseline through post-operative day 3

• Units of Packed Red Blood Cells (pRBCs) Transfused

  baseline through post-operative day 3

Study Arms (2)

Vitagel and Standard of Care

EXPERIMENTAL

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

Device: Vitagel; Procedure: Standard of care

Standard of Care

ACTIVE COMPARATOR

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.

Procedure: Standard of care

Interventions

Vitagel DEVICE

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.

Vitagel and Standard of Care

Standard of care PROCEDURE

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

Standard of Care; Vitagel and Standard of Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (12)

• Thoms RJ, Marwin SE. The role of fibrin sealants in orthopaedic surgery. J Am Acad Orthop Surg. 2009 Dec;17(12):727-36. doi: 10.5435/00124635-200912000-00001.

  PMID: 19948697 BACKGROUND

• Gardner MJ, Demetrakopoulos D, Klepchick PR, Mooar PA. The efficacy of autologous platelet gel in pain control and blood loss in total knee arthroplasty. An analysis of the haemoglobin, narcotic requirement and range of motion. Int Orthop. 2007 Jun;31(3):309-13. doi: 10.1007/s00264-006-0174-z. Epub 2006 Jul 1.

  PMID: 16816947 BACKGROUND

• Zavadil DP, Satterlee CC, Costigan JM, Holt DW, Shostrom VK. Autologous platelet gel and platelet-poor plasma reduce pain with total shoulder arthroplasty. J Extra Corpor Technol. 2007 Sep;39(3):177-82.

  PMID: 17972452 BACKGROUND

• Everts PA, Devilee RJ, Brown Mahoney C, Eeftinck-Schattenkerk M, Box HA, Knape JT, van Zundert A. Platelet gel and fibrin sealant reduce allogeneic blood transfusions in total knee arthroplasty. Acta Anaesthesiol Scand. 2006 May;50(5):593-9. doi: 10.1111/j.1399-6576.2006.001005.x.

  PMID: 16643230 BACKGROUND

• Horstmann WG, Slappendel R, van Hellemondt GG, Wymenga AW, Jack N, Everts PA. Autologous platelet gel in total knee arthroplasty: a prospective randomized study. Knee Surg Sports Traumatol Arthrosc. 2011 Jan;19(1):115-21. doi: 10.1007/s00167-010-1207-0. Epub 2010 Jul 18.

  PMID: 20640848 BACKGROUND

• Wang GJ, Hungerford DS, Savory CG, Rosenberg AG, Mont MA, Burks SG, Mayers SL, Spotnitz WD. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Surg Am. 2001 Oct;83(10):1503-5. doi: 10.2106/00004623-200110000-00007.

  PMID: 11679600 BACKGROUND

• Wang GJ, Goldthwaite CA Jr, Burks S, Crawford R, Spotnitz WD; Orthopaedic Investigators Group. Fibrin sealant reduces perioperative blood loss in total hip replacement. J Long Term Eff Med Implants. 2003;13(5):399-411. doi: 10.1615/jlongtermeffmedimplants.v13.i5.50.

  PMID: 14649578 BACKGROUND

• Sherman R, Chapman WC, Hannon G, Block JE. Control of bone bleeding at the sternum and iliac crest donor sites using a collagen-based composite combined with autologous plasma: results of a randomized controlled trial. Orthopedics. 2001 Feb;24(2):137-41. doi: 10.3928/0147-7447-20010201-16.

  PMID: 11284596 BACKGROUND

• Levy O, Martinowitz U, Oran A, Tauber C, Horoszowski H. The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study. J Bone Joint Surg Am. 1999 Nov;81(11):1580-8. doi: 10.2106/00004623-199911000-00010.

  PMID: 10565650 BACKGROUND

• Cillo JE Jr, Marx RE, Stevens MR. Evaluation of autologous platelet-poor plasma gel as a hemostatic adjunct after posterior iliac crest bone harvest. J Oral Maxillofac Surg. 2007 Sep;65(9):1734-8. doi: 10.1016/j.joms.2006.09.008.

  PMID: 17719390 BACKGROUND

• Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion medicine. First of two parts--blood transfusion. N Engl J Med. 1999 Feb 11;340(6):438-47. doi: 10.1056/NEJM199902113400606. No abstract available.

  PMID: 9971869 BACKGROUND

• Busch MP, Kleinman SH, Nemo GJ. Current and emerging infectious risks of blood transfusions. JAMA. 2003 Feb 26;289(8):959-62. doi: 10.1001/jama.289.8.959. No abstract available.

  PMID: 12597733 BACKGROUND

Related Links

• UT-Houston Department of Orthopaedic Surgery

MeSH Terms

Conditions

Intra-Articular Fractures; Fractures, Bone

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Catherine G. Ambrose, PhD
• Organization: The University of Texas Health Science Center at Houston

Catherine.G.Ambrose@uth.tmc.edu

Study Officials

• Catherine G Ambrose, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 29, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 11, 2018
• Results First Posted: November 15, 2018

Record last verified: 2018-11

Locations

US (1)