Coronary Artery DiseaseNCT05229276
Efficacy of Sternum Guard in Post Cardiac Surgery Patient
A study testing Sternum Guard and Bone Wax in people with Coronary Artery Disease and Valvular Heart Disease, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Valvular Heart Disease, Congenital Heart Disease in Adolescence
- What is being tested?
- Sternum Guard and Bone Wax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 May 2020to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Center Harapan Kita
Jakarta, DKI Jakarta, 11410
About this study
Official title: Efficacy of Sternum GuardTM in Comparison of Bone Wax in Post Cardiac Surgery Patient: A Single Blind, Single Centre, Randomized Control Trial
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease, Congenital Heart Disease in Adolescence, Post Operative Wound Infection, Surgical Site Infection, Postoperative Hemorrhage
- Being tested
- Sternum Guard, Bone Wax
- Keywords
- Sternum Guard, Bone Wax, Median sternotomy, surgical site infection, operative blood loss
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases, Surgical Wound Infection, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sternum GuardOther
Also called Sternum GuardTM, Vygon, Netherlands, product code 40.90.11
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 WaxOther
Also called Bone Wax, Braun Aesculap AG & CO. KG, Duisburg, Germany
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.
| Study group | Role | What they receive |
|---|---|---|
| Sternum Guard | Experimental | The treatment of interest was Sternum GuardTM application during sternotomy. Receives: Other: Sternum Guard |
| Bone wax | Active comparator | The 'bone wax' arm was the control group of active comparator as the widely-used materials during sternotomy. Receives: Other: Bone Wax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start17 May 2020
- Primary completion8 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Vygon GmbH & Co. KG
- Responsible party
- Principal investigator, Dudy Arman Hanafy, Sp. BTKV (K), MARS, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Komite Etik of National Cardiovascular Center Harapan Kita, Study chair, Ethical Committee of National Cardiovascular Center Harapan Kita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229276
- Sponsor's protocol ID
- LB.02.01/VII/402/KEP.097/2019
- Other IDs
- 1706100560
- Status last verified
- Feb 2022
- First submitted
- 9 Nov 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Ohta S, Nishiyama T, Sakoda M, Machioka K, Fuke M, Ichimura S, Inagaki F, Shimizu A, Hasegawa K, Kokudo N, Kaneko M, Yatomi Y, Ito T. Development of carboxymethyl cellulose nonwoven sheet as a novel hemostatic agent. J Biosci Bioeng. 2015 Jun;119(6):718-23. doi: 10.1016/j.jbiosc.2014.10.026. Epub 2014 Dec 3.
PubMed 25488042Lewis KM, Spazierer D, Urban MD, Lin L, Redl H, Goppelt A. Comparison of regenerated and non-regenerated oxidized cellulose hemostatic agents. Eur Surg. 2013;45(4):213-220. doi: 10.1007/s10353-013-0222-z. Epub 2013 Jul 4.
PubMed 23950762Schonauer C, Tessitore E, Barbagallo G, Albanese V, Moraci A. The use of local agents: bone wax, gelatin, collagen, oxidized cellulose. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S89-96. doi: 10.1007/s00586-004-0727-z. Epub 2004 Jun 22.
PubMed 15221572Liu Z, Dumville JC, Norman G, Westby MJ, Blazeby J, McFarlane E, Welton NJ, O'Connor L, Cawthorne J, George RP, Crosbie EJ, Rithalia AD, Cheng HY. Intraoperative interventions for preventing surgical site infection: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2018 Feb 6;2(2):CD012653. doi: 10.1002/14651858.CD012653.pub2.
PubMed 29406579
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sternum GuardTM in Comparison of Bone Wax in Post Cardiac Surgery Patient: A Single Blind, Single Centre, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05229276
- Acronym / sponsor ID
- LB.02.01/VII/402/KEP.097/2019
- Conditions
- Coronary Artery Disease, Valvular Heart Disease, Congenital Heart Disease in Adolescence, Post Operative Wound Infection, Surgical Site Infection, Postoperative Hemorrhage
- Keywords
- Sternum Guard, Bone Wax, Median sternotomy, surgical site infection, operative blood loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Vygon GmbH & Co. KG
- Study start
- 17 May 2020 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sternum Guard | Experimental | Other: Sternum GuardThe treatment of interest was Sternum GuardTM application during sternotomy. |
| Bone wax | Active comparator | Other: Bone WaxThe 'bone wax' arm was the control group of active comparator as the widely-used materials during sternotomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
- Patients who are pronounced death on operation table
- Patients who are pronounced death within hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sternum GuardAlso: Sternum GuardTM, Vygon, Netherlands, product code 40.90.11The 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 | Sternum Guard |
| Bone WaxAlso: Bone Wax, Braun Aesculap AG & CO. KG, Duisburg, Germanypatients 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 | Bone wax |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Results publication: PubMed 25488042Ohta S, Nishiyama T, Sakoda M, Machioka K, Fuke M, Ichimura S, Inagaki F, Shimizu A, Hasegawa K, Kokudo N, Kaneko M, Yatomi Y, Ito T. Development of carboxymethyl cellulose nonwoven sheet as a novel hemostatic agent. J Biosci Bioeng. 2015 Jun;119(6):718-23. doi: 10.1016/j.jbiosc.2014.10.026. Epub 2014 Dec 3.
- Results publication: PubMed 23950762Lewis KM, Spazierer D, Urban MD, Lin L, Redl H, Goppelt A. Comparison of regenerated and non-regenerated oxidized cellulose hemostatic agents. Eur Surg. 2013;45(4):213-220. doi: 10.1007/s10353-013-0222-z. Epub 2013 Jul 4.
- Results publication: PubMed 15221572Schonauer C, Tessitore E, Barbagallo G, Albanese V, Moraci A. The use of local agents: bone wax, gelatin, collagen, oxidized cellulose. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S89-96. doi: 10.1007/s00586-004-0727-z. Epub 2004 Jun 22.
- Results publication: PubMed 29406579Liu Z, Dumville JC, Norman G, Westby MJ, Blazeby J, McFarlane E, Welton NJ, O'Connor L, Cawthorne J, George RP, Crosbie EJ, Rithalia AD, Cheng HY. Intraoperative interventions for preventing surgical site infection: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2018 Feb 6;2(2):CD012653. doi: 10.1002/14651858.CD012653.pub2.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Komite Etik of National Cardiovascular Center Harapan Kita study chair
Ethical Committee of National Cardiovascular Center Harapan Kita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sternum Guard and Bone Wax in people with Coronary Artery Disease and Valvular Heart Disease, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: within 30 days after the sternotomy surgery performed). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05229276, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.