Clinical trial NCT05229276: Efficacy of Sternum Guard in Post Cardiac Surgery Patient
Official title: Efficacy of Sternum GuardTM in Comparison of Bone Wax in Post Cardiac Surgery Patient: A Single Blind, Single Centre, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Valvular Heart Disease
Congenital Heart Disease in Adolescence
Post Operative Wound Infection
Surgical Site Infection
Postoperative Hemorrhage
Keywords: Sternum Guard
Bone Wax
Median sternotomy
surgical site infection
operative blood loss
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Vygon GmbH & Co. KG
First posted: 2022-02-08
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blind, single center, parallel phase 4 randomized clinical trial was conducted with two intervention arms: an intervention arm with the use of Sternum GuardTM and a control arm with the use of bone wax in which the subjects' recruitment and treatment were conducted simultaneously by means of a block randomization.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical site infection
timeFrame: within 30 days after the sternotomy surgery performed
measure: Haemostatic effect
timeFrame: immediately after the median sternotomy surgery finished
measure: Satisfaction rate
timeFrame: within 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
state: DKI Jakarta
Study officials:
affiliation: Ethical Committee of National Cardiovascular Center Harapan Kita
name: Komite Etik of National Cardiovascular Center Harapan Kita
role: STUDY_CHAIR
References:
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):718-23. doi: 10.1016/j.jbiosc.2014.10.026. Epub 2014 Dec 3.
citation: 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(4):213-220. doi: 10.1007/s10353-013-0222-z. Epub 2013 Jul 4.
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(Suppl 1):S89-96. doi: 10.1007/s00586-004-0727-z. Epub 2004 Jun 22.
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. Cochrane Database Syst Rev. 2018 Feb 6;2(2):CD012653. doi: 10.1002/14651858.CD012653.pub2.