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Completed

NCT Number: NCT05229276

Efficacy of Sternum Guard in Post Cardiac Surgery Patient

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Congenital Heart Disease in Adolescence Coronary Disease Heart Diseases Heart Valve Diseases Hemorrhage Infections Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Wound Infection Postoperative Complications Postoperative Hemorrhage Surgical Site Infection Surgical Wound Infection Valvular Heart Disease Vascular Diseases Wound Infection

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, 11410, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sternum Guard

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

Other names: Sternum GuardTM, Vygon, Netherlands, product code 40.90.11

Bone Wax

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.

Other names: Bone Wax, Braun Aesculap AG & CO. KG, Duisburg, Germany

Primary outcomes

  1. Surgical site infection

    Time frame: 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.

  2. Haemostatic effect

    Time frame: 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.

  3. Satisfaction rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Vygon GmbH & Co. KG

Registry information

Official study title

Efficacy of Sternum GuardTM in Comparison of Bone Wax in Post Cardiac Surgery Patient: A Single Blind, Single Centre, Randomized Control Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2022
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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