- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05229276
Efficacy of Sternum Guard in Post Cardiac Surgery Patient
Efficacy of Sternum GuardTM in Comparison of Bone Wax in Post Cardiac Surgery Patient: A Single Blind, Single Centre, Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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DKI Jakarta
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Jakarta, DKI Jakarta, Indonesia, 11410
- National Cardiovascular Center Harapan Kita
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients ages > 18 years old
- Patients who are scheduled electively for cardiac surgery
- Cardiac surgery with the usage of cardiopulmonary bypass machine
- Patients who are agreed to participate in this study
Exclusion Criteria:
- Patients who are scheduled for surgery in emergency or urgent manner
- Patients with the history of uncontrolled hypertension and uncontrolled diabetes mellitus.
- Patients with the history of past cardiac surgery
Drop - out Criteria:
- Patients who are pronounced death on operation table
- Patients who are pronounced death within hospitalization
- Patients who are lost to follow up (Day 30 post-operative)
- Patients who are not committed for the whole stage of the research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Sternum Guard
The treatment of interest was Sternum GuardTM application during sternotomy.
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The intervention being assessed is a surgical drape used as a cover of sternal bones and the neighboring structures exposed during median sternotomy named Sternum Guard. Sternum guard® is a single use, sterile surgical drape with modified cellulose designed specifically to reduce the risk of surgical site infection (SSI). It is made of 4 parts, the main part is in contact with the retractors and the sternum edge. It is made of carboxymethylated cellulose (CMC) spunlace which makes direct contact with the sternum edges. It contributes to blood absorption, to decreasing of pH environment, and to haemostatic action through a physical effect (compression); another part was made from hydrophilic spunbond (swabs) allowing blood absorption, comfort and protection
Other Names:
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Active Comparator: Bone wax
The 'bone wax' arm was the control group of active comparator as the widely-used materials during sternotomy.
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patients in this group were given Bone Wax as the hemostatic material during sternotomy.
Midline sternotomy with an oscillating saw was conducted after standard aseptic surgical techniques.
Bone wax was applied to both spongiosa surfaces of resected sternal bones until bleeding had ceased.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Surgical site infection
Time Frame: within 30 days after the sternotomy surgery performed
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A surgical site infection is an infection occurring within 30 days after the operation and only involving the skin and subcutaneous tissue (superficial) or involving deep soft tissues (fibrous connective tissues and muscle layers) of the post-surgical incision wounds. Superficial surgical site infections is identified by at least one of the following: purulent drainage, organisms isolated from an aseptically-obtained culture of fluid or tissue from the surgical site, presence of signs or symptoms of infection: pain or tenderness, localised swelling, redness or heat, or diagnosis of SSI by the surgeon or attending physician. A deep incisional SSI is an infection appears to be related to the operative procedure and involves deep soft tissues which is indicated by either; purulent drainage, a deep incision spontaneously dehisces, an abscess, diagnosis of a deep incisional SSI by a surgeon or attending physician. |
within 30 days after the sternotomy surgery performed
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Haemostatic effect
Time Frame: immediately after the median sternotomy surgery finished
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It will assess the quantity of blood lost from the sternal edges in Sternum GuardTM and Bone Wax group.
The Sternum GuardTM and sterile drapes will be weighed before and after surgery to estimate the blood lost.
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immediately after the median sternotomy surgery finished
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Satisfaction rate
Time Frame: within 24 hours after surgery
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A rating value from the surgeon as the user of the materials being investigated in terms of satisfaction upon the performance and practicality of the either materials from surgeon's personal opinion.
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within 24 hours after surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Komite Etik of National Cardiovascular Center Harapan Kita, Ethical Committee of National Cardiovascular Center Harapan Kita
Publications and helpful links
General Publications
- Ohta S, Nishiyama T, Sakoda M, Machioka K, Fuke M, Ichimura S, Inagaki F, Shimizu A, Hasegawa K, Kokudo N, Kaneko M, Yatomi Y, Ito T. Development of carboxymethyl cellulose nonwoven sheet as a novel hemostatic agent. J Biosci Bioeng. 2015 Jun;119(6):718-23. doi: 10.1016/j.jbiosc.2014.10.026. Epub 2014 Dec 3.
- Lewis KM, Spazierer D, Urban MD, Lin L, Redl H, Goppelt A. Comparison of regenerated and non-regenerated oxidized cellulose hemostatic agents. Eur Surg. 2013;45(4):213-220. doi: 10.1007/s10353-013-0222-z. Epub 2013 Jul 4.
- Schonauer C, Tessitore E, Barbagallo G, Albanese V, Moraci A. The use of local agents: bone wax, gelatin, collagen, oxidized cellulose. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S89-96. doi: 10.1007/s00586-004-0727-z. Epub 2004 Jun 22.
- Liu Z, Dumville JC, Norman G, Westby MJ, Blazeby J, McFarlane E, Welton NJ, O'Connor L, Cawthorne J, George RP, Crosbie EJ, Rithalia AD, Cheng HY. Intraoperative interventions for preventing surgical site infection: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2018 Feb 6;2(2):CD012653. doi: 10.1002/14651858.CD012653.pub2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Postoperative Complications
- Disease Attributes
- Congenital Abnormalities
- Coronary Disease
- Cardiovascular Abnormalities
- Heart Diseases
- Coronary Artery Disease
- Infections
- Communicable Diseases
- Hemorrhage
- Heart Defects, Congenital
- Surgical Wound Infection
- Wound Infection
- Heart Valve Diseases
- Postoperative Hemorrhage
- Hemostatics
- Coagulants
- Bone wax
Other Study ID Numbers
- LB.02.01/VII/402/KEP.097/2019
- 1706100560 (Other Identifier: University of Indonesia - Harapan Kita National Heart Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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