An interventional study of Sternum Guard and Bone Wax in Coronary Artery Disease, Valvular Heart Disease and Congenital Heart Disease in Adolescence, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-02-08.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 414 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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The treatment of interest was Sternum GuardTM application during sternotomy.
Other: Sternum Guard
The 'bone wax' arm was the control group of active comparator as the widely-used materials during sternotomy.
Other: Bone Wax
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
Also known as: Sternum GuardTM, Vygon, Netherlands, product code 40.90.11
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.
Also known as: Bone Wax, Braun Aesculap AG & CO. KG, Duisburg, Germany
Surgical site infection
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.
Time frame: within 30 days after the sternotomy surgery performed
Haemostatic effect
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.
Time frame: immediately after the median sternotomy surgery finished
Satisfaction rate
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.
Time frame: within 24 hours after surgery
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — the study protocol, ethical clearance letter, the primary database of the study, as well as the study's analysis plan and the manuscript of the study will be made available on the permission by the grant provider and ethical committee
Supporting information: Study protocol, Icf, Csr
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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