Efficacy of Sternum Guard in Post Cardiac Surgery Patient

University of Indonesia (UI)

Status: Completed

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

Treatments: Other: Sternum Guard; Other: Bone Wax

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05229276

1706100560 (Other Identifier)

LB.02.01/VII/402/KEP.097/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 414 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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414 participants in 2 patient groups

Sternum Guard

Experimental group

Description:

The treatment of interest was Sternum GuardTM application during sternotomy.

Treatment:

Other: Sternum Guard

Bone wax

Active Comparator group

Description:

The 'bone wax' arm was the control group of active comparator as the widely-used materials during sternotomy.

Treatment:

Other: Bone Wax