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

Intra-Articular Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01230931
• Other study ID #: HSC-MS-09-0654
• Status: Terminated
• Phase: N/A
• Start date: October 2010
• Est. completion date: April 2012

Study information

• Verified date: November 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acetabulum
• Fracture Fixation
• Fractures, Bone
• Intra-Articular Fractures

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (12)

Busch MP, Kleinman SH, Nemo GJ. Current and emerging infectious risks of blood transfusions. JAMA. 2003 Feb 26;289(8):959-62. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jul 1. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Thoms RJ, Marwin SE. The role of fibrin sealants in orthopaedic surgery. J Am Acad Orthop Surg. 2009 Dec;17(12):727-36. Review. — View Citation

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. — View Citation

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-A(10):1503-5. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Hemoglobin Level	The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.	baseline, post-operative day 1
Secondary	Change in Hemoglobin Level	The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.	baseline, post-operative day 2
Secondary	Change in Hemoglobin Level	The amount of change in hemoglobin level from before surgery on the operative day until post-operative day numbers one, two, or three.	baseline, post-operative day 3
Secondary	Volume of Blood Products Transfused	The amount of blood products [packed red blood cells (pRBCs), fresh frozen plasma (FFP), intra-operative salvaged blood collected with a cell saver] transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3.	baseline through post-operative day 3
Secondary	Units of Packed Red Blood Cells (pRBCs) Transfused	The amount of blood products [packed red blood cells (pRBCs), fresh frozen plasma (FFP), intra-operative salvaged blood collected with a cell saver] transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3.	baseline through post-operative day 3
Secondary	Units of Fresh Frozen Plasma (FFP) Transfused	The amount of blood products (pRBCs and FFP) transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3. Intra-operative salvaged blood will be recovered with a cell saver, and if cell saver units are transfused, this will also be recorded on the operative day and on post-operative days 1, 2, and 3.	baseline through post-operative day 3
Secondary	Volume of Intra-operative Salvaged Blood Transfused	The amount of blood products (pRBCs and FFP) transfused will be recorded throughout the operative day and on post-operative days 1, 2, and 3. Intra-operative salvaged blood will be recovered with a cell saver, and if cell saver units are transfused, this will also be recorded on the operative day and on post-operative days 1, 2, and 3.	baseline through post-operative day 3
Secondary	Number of Participants With a Wound Complication	The number of wound complications (dehiscence, infection) or the need to return to the operating to address a wound complication will be recorded. Wound complications will be recorded from the day of surgery until an average of two weeks post-operatively (this study is an acute care study, so no data will be collected after the initial hospital stay).	at the time of discharge (about 2 weeks after surgery)

External Links

•   UT-Houston Department of Orthopaedic Surgery