Efficacy of Sternum Guard in Post Cardiac Surgery Patient

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Efficacy of Sternum GuardTM in Comparison of Bone Wax in Post Cardiac Surgery Patient: A Single Blind, Single Centre, Randomized Control Trial

Conditions
-----------------
Coronary Artery Disease, Valvular Heart Disease, Congenital Heart Disease in Adolescence, Post Operative Wound Infection, Surgical Site Infection, Postoperative Hemorrhage

Intervention / Treatment
-----------------
* Other: Sternum Guard
* Other: Bone Wax


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A single-blind, single center, parallel phase 4 randomized clinical trial was conducted with two intervention arms: an intervention arm with the use of Sternum GuardTM and a control arm with the use of bone wax in which the subjects' recruitment and treatment were conducted simultaneously by means of a block randomization.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sternum Guard<br>The treatment of interest was Sternum GuardTM application during sternotomy. | Other: Sternum Guard<br>* 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<br>* Other names: Sternum GuardTM, Vygon, Netherlands, product code 40.90.11;|
| Active Comparator: Bone wax<br>The 'bone wax' arm was the control group of active comparator as the widely-used materials during sternotomy. | Other: Bone Wax<br>* 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.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sternum Guard, Bone Wax, Median sternotomy, surgical site infection, operative blood loss