Efficacy of Sternum Guard in Post Cardiac Surgery Patient

Coronary Artery Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Congenital Heart Disease in Adolescence
• Coronary Artery Disease
• Heart Defects, Congenital
• Heart Diseases
• Heart Valve Diseases
• Hemorrhage
• Infections
• Post Operative Wound Infection
• Postoperative Hemorrhage
• Surgical Site Infection
• Surgical Wound Infection
• Valvular Heart Disease
• Wound Infection

• NCT number: NCT05229276
• Study type: Interventional
• Source: Indonesia University
• Status: Completed
• Phase: N/A
• Start date: May 17, 2020
• Completion date: October 30, 2021