Efficacy of Sternum Guard in Post Cardiac Surgery Patient
Condition: Coronary Artery Disease; Valvular Heart Disease; Congenital Heart Disease in Adolescence; Post Operative Wound Infection; Surgical Site Infection; Postoperative Hemorrhage
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Coronary Artery Disease; Heart Diseases; Heart Defects, Congenital; Heart Valve Diseases; Hemorrhage; Postoperative Hemorrhage; Surgical Wound
Study type: Interventional

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.
    

Intervention name(s): Sternum Guard; Bone Wax
Intervention type(s): Other; Other
Intervention description(s): 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; 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 intervention name(s): Sternum GuardTM, Vygon, Netherlands, product code 40.90.11; Bone Wax, Braun Aesculap AG & CO. KG, Duisburg, Germany
Intervention MeSH terms: Bone wax
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sternum Guard; Bone Wax; Median sternotomy; surgical site infection; operative blood loss