Efficacy of Sternum Guard in Post Cardiac Surgery Patient

Not Applicable

Completed

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

• Registration Number: NCT05229276
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2020-05-17
• Primary Completion: 2021-10-08
• Study Completion: 2021-10-30
• Study First Submitted: 2021-11-09
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Study First Posted: 2022-02-08
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sternum Guard	Sternum Guard	The treatment of interest was Sternum GuardTM application during sternotomy.
Bone wax	Bone Wax	The 'bone wax' arm was the control group of active comparator as the widely-used materials during sternotomy.

Primary Outcome Measures

Name	Time	Method
Haemostatic effect	immediately after the median sternotomy surgery finished	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.
Satisfaction rate	within 24 hours after surgery	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.
Surgical site infection	within 30 days after the sternotomy surgery performed	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.

Trial Locations

Locations (1)

National Cardiovascular Center Harapan Kita; 🇮🇩 Jakarta, DKI Jakarta, Indonesia