Efficacy of Sternum Guard in Post Cardiac Surgery Patient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-17

Study Completion Date

2021-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Subjects/participants were not aware of the arms/treatment given as they were under general anesthesia during the application of interventions being studied. Besides, during the informed consent for the elective sternotomy procedure, subjects were extensively given explanation of the purpose, methods, benefits and risks of the procedure including the randomized nature of the allocation to either arms of the study.

Principal investigators as well as outcomes assessor were kept unaware of the randomization of interventions as they both were restricted for assessing the patients' medical record and the patient identity were coded in the primary database.

Study Groups

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Sternum Guard

The treatment of interest was Sternum GuardTM application during sternotomy.

Group Type EXPERIMENTAL

Sternum Guard

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Bone Wax

Intervention Type OTHER

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.

Interventions

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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

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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Sternum GuardTM, Vygon, Netherlands, product code 40.90.11 Bone Wax, Braun Aesculap AG & CO. KG, Duisburg, Germany

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No