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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229276
• Other study ID #: LB.02.01/VII/402/KEP.097/2019
• Secondary ID: 1706100560
• Status: Completed
• Phase: N/A
• Start date: May 17, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: February 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: October 30, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

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

Intervention

Other:
• Sternum Guard
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
• Bone Wax
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.

Locations

Country	Name	City	State
Indonesia	National Cardiovascular Center Harapan Kita	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Vygon GmbH & Co. KG

Country where clinical trial is conducted

Indonesia, 

References & Publications (4)

Lewis KM, Spazierer D, Urban MD, Lin L, Redl H, Goppelt A. Comparison of regenerated and non-regenerated oxidized cellulose hemostatic agents. Eur Surg. 2013;45:213-220. Epub 2013 Jul 4. — View Citation

Liu Z, Dumville JC, Norman G, Westby MJ, Blazeby J, McFarlane E, Welton NJ, O'Connor L, Cawthorne J, George RP, Crosbie EJ, Rithalia AD, Cheng HY. Intraoperative interventions for preventing surgical site infection: an overview of Cochrane Reviews. Cochra — View Citation

Ohta S, Nishiyama T, Sakoda M, Machioka K, Fuke M, Ichimura S, Inagaki F, Shimizu A, Hasegawa K, Kokudo N, Kaneko M, Yatomi Y, Ito T. Development of carboxymethyl cellulose nonwoven sheet as a novel hemostatic agent. J Biosci Bioeng. 2015 Jun;119(6):718-2 — View Citation

Schonauer C, Tessitore E, Barbagallo G, Albanese V, Moraci A. The use of local agents: bone wax, gelatin, collagen, oxidized cellulose. Eur Spine J. 2004 Oct;13 Suppl 1:S89-96. Epub 2004 Jun 22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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