CompletedNot Applicable

Efficacy of Sternum Guard in Post Cardiac Surgery Patient

Indonesia414 participantsStarted 2020-05-17

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Surgical site infection

Timeframe: within 30 days after the sternotomy surgery performed

Haemostatic effect

Timeframe: immediately after the median sternotomy surgery finished

Satisfaction rate

Timeframe: within 24 hours after surgery

Trial details

NCT IDNCT05229276

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-08