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

This is a single-center, single-blind, randomized parallel superiority trial comparing two groups; Sternum GuardTM as the treatment arm and Bone Wax as the active control group. Both investigated modalities are materials used during sternotomy for covering the sewn sternal edge. The primary outcomes of this study comprised of four parameters; namely surgical site infection (superficial or deep infection), sternal dehiscence, hemostatic effect, and surgeon's satisfaction rate. The first three primary outcomes were assessed during the operation, at the end of the hospital stay, 14 days, and 30-days postoperative.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Surgical Site Infection; Postoperative Hemorrhage; Valvular Heart Disease; Congenital Heart Disease in Adolescence; Post Operative Wound Infection
• Intervention / Treatment: Other: Sternum Guard; Other: Bone Wax

Detailed Description

A single center randomized controlled clinical trial was conducted at Harapan Kita National Cardiovascular Center, Jakarta, Indonesia as the tertiary cardiovascular referral hospital. The RCT was conducted from May 17th, 2020 until October 20th, 2021 (current status: completed). This study assessed the efficacy of Sternum GuardTM, a commercially-available nonwoven cellulose based, single use, sterile surgical drape used for covering the dissected sternal bone edge during median sternotomy for cardiac surgery. The active comparator/ control group in this study is the use of Bone wax, a vaseline and beeswax-made materials widely used during sternotomy as a mean of bleeding control. The subjects were adults undergoing elective cardiac surgery with median sternotomy approach for any indication. Both the patients and the principal investigators were blinded for the treatment-control allocation, but the surgeon were not blinded for the materials used. The patients were purposively selected and were randomly assigned to one of the arms with block randomization. The primary outcomes of this study comprised of four parameters; namely surgical site infection (superficial or deep infection), sternal dehiscence, hemostatic effect, and surgeon's satisfaction rate. The first three primary outcomes were assessed during the operation, at the end of the hospital stay, 14 days, and 30-days postoperative. The minimum sample size was 414 subjects.

• Study Type: Interventional
• Enrollment (Actual): 414
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 11410
      • National Cardiovascular Center Harapan Kita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sternum Guard; The treatment of interest was Sternum GuardTM application during sternotomy.	Other: Sternum Guard; 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: Sternum GuardTM, Vygon, Netherlands, product code 40.90.11
Active Comparator: Bone wax; The 'bone wax' arm was the control group of active comparator as the widely-used materials during sternotomy.	Other: Bone Wax; 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: Bone Wax, Braun Aesculap AG & CO. KG, Duisburg, Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection	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
Haemostatic effect	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.	immediately after the median sternotomy surgery finished
Satisfaction rate	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.	within 24 hours after surgery

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Vygon GmbH & Co. KG
• 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): May 17, 2020
• Primary Completion (Actual): October 8, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: surgical site infection; operative blood loss; Sternum Guard; Bone Wax; Median sternotomy
• 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)?: Yes
• IPD Plan Description: the study protocol, ethical clearance letter, the primary database of the study, as well as the study's analysis plan and the manuscript of the study will be made available on the permission by the grant provider and ethical committee
• IPD Sharing Time Frame: November 30, 2021 for 2 (two) years
• IPD Sharing Access Criteria: for peer-reviewing or for further analysis or when needed by authors of a systematic review/meta analysis of randomized controlled trials
• 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: No
• Studies a U.S. FDA-regulated device product: No