Efficacy of Sternum Guard in Post Cardiac Surgery Patient

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06030596` - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed	`NCT04080700` - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting	`NCT03810599` - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study	N/A
Recruiting	`NCT06002932` - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.	N/A
Not yet recruiting	`NCT06032572` - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)	N/A
Recruiting	`NCT05308719` - Nasal Oxygen Therapy After Cardiac Surgery	N/A
Recruiting	`NCT04242134` - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions	N/A
Completed	`NCT04556994` - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.	N/A
Recruiting	`NCT05846893` - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease	N/A
Recruiting	`NCT06027788` - CTSN Embolic Protection Trial	N/A
Recruiting	`NCT05023629` - STunning After Balloon Occlusion	N/A
Completed	`NCT04941560` - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed	`NCT04006288` - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease	Phase 4
Completed	`NCT01860274` - Meshed Vein Graft Patency Trial - VEST	N/A
Recruiting	`NCT06174090` - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients	N/A
Terminated	`NCT03959072` - Cardiac Cath Lab Staff Radiation Exposure
Completed	`NCT03968809` - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Recruiting	`NCT05065073` - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography	Phase 4
Recruiting	`NCT04566497` - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.	N/A
Completed	`NCT05096442` - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions	N/A