Cardiac Surgery, Bone Wax, NU-KNIT, Median Sternotomy, Deep Sternal Wound Infection, Surgical Site InfectionNBCSNCT06869772
Surgicel NU-KNIT Vs Bone Wax on Median Sternotomy
A study testing Closure of sternotomy in people with Cardiac Surgery, Bone Wax, NU-KNIT, Median Sternotomy, Deep Sternal Wound Infection, Surgical Site Infection, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Bone wax is traditionally used as part of surgical procedures to prevent bleeding from exposed spongy bone. It is an effective hemostatic device which creates a physical barrier. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Surgery, Bone Wax, NU-KNIT, Median Sternotomy, Deep Sternal Wound Infection, Surgical Site Infection
- What is being tested?
- Closure of sternotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteQatar
- Study dates
- 10 Sep 2021to 31 Jan 2022
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All Patients that will undergo coronary artery bypass graft surgery (CABG) using cardiopulmonary bypass (CBP) with single internal mammary artery harvest will be selected and randomized into 2 groups.
Who cannot join
- Emergency procedures, patients with blood coagulopathies and patients who underwent re-exploration for hemorrhage after 24 hours of surgery (as sternal re-exploration increase the risk of sternal infection per se and hence this might affect the study's secondary outcome of assessing the rate of wound infection), CABG with bilateral internal mammary artery harvest, and valves surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing of Surgicel NU-KNIT and Bone Wax and Their Impacts on Median Sternotomy Wound Infection and Bleeding. Randomized Clinical Trial
Bone wax is traditionally used as part of surgical procedures to prevent bleeding from exposed spongy bone. It is an effective hemostatic device which creates a physical barrier. Unfortunately, it interferes with subsequent bone healing and increases the risk of infection in experimental studies, with its subsequent an infrequent but devastating complication, deep sternal wound infections and mediastinitis are associated with increased mortality, repeated surgical procedures, prolonged hospital stay, and increased (1-3) costs. We aim at finding whether Oxidized regenerated cellulose (ORC) concomitant with electrocauterization provided additional clinical benefit in the cardiac surgery patient who had sternotomy incision.
Primary objective: The impact of BW with electrocauterization, and Oxidized regenerated cellulose (ORC) concomitant with electrocauterization on the rate of sternotomy wound infection after a month of the surgery.
Read more
Secondary objective: The impact of using Oxidized regenerated cellulose (ORC) concomitant on the post-operative drainage and blood products need.
Study Methodology
A prospective, randomized controlled study to be conducted from the time of ethical approval for 12 months. Patients that will undergo coronary artery bypass graft surgery (CABG) using cardiopulmonary bypass (CBP) with single internal mammary artery harvest will be selected and randomized into 2 groups according to chronological order. The first group will receive BW (Bone-wax?, Aesculap Inc., USA) concomitant with electrocauterization, and we will use oxidized regenerated cellulose (ORC) (Surgicel NU-KNIT? Absorbable Hemostat, Ethicon Inc., USA) concomitant with electrocauterization the second group received.
One week prior to the surgery all anticoagulant and antiplatelet medications should be stopped. All coagulation tests will be done preoperatively and postoperatively including platelet counts, international normalized ratio and activated partial thromboplastin time.
We will follow the patient for one month post-operatively by our specialized wound nurse care for detection any wound infection and we will use CDC definition for surgical site infection for that purpose.
As a secondary outcome, blood drainage amounts will be recorded at the postoperative 1st, 2nd, 3rd, 6th, 12th and 24th hours. The number of units of blood and its products used will be also studied.
Demographic data will be collected through electronic data base system in our corporate after approval from the institutional review board.
Surgical technique Surgical intervention will be done through a median sternotomy with CBP, moderate hypothermia, and cold blood cardioplegia in all CABG patients.
In group I, spreading of BW on the sternal surfaces by digital pressure immediately after sternotomy and before closing the chest. In group II ORC will be cut and laid along the sternotomy over the intramedullary area immediately after sternotomy and it will be removed before closing the chest.
Routine prophylactic antibiotics will be used according to our protocol, during the skin incision. The activated coagulation time levels were measured and adjusted between 100 and 150 s postoperatively.
Clopidogrel plus Salicylic acid in case CABG surgery and Warfarin 3 mg (as starting dose) plus Enoxaparin sodium 1 mg/kg SC twice daily in case of valve surgery, will be started on the postoperative second day if no expectation for further bleeding and adequate hemostasis has been achieved.
Read the detailed description
We aim at finding whether Oxidized regenerated cellulose (ORC) concomitant with electrocauterization provided additional clinical benefit in the cardiac surgery patient who had sternotomy incision.
Primary objective: The impact of BW with electrocauterization, and Oxidized regenerated cellulose (ORC) concomitant with electrocauterization on the rate of sternotomy wound infection after a month of the surgery.
Secondary objective: The impact of using Oxidized regenerated cellulose (ORC) concomitant on the post-operative drainage and blood products need.
Study Methodology
A prospective, randomized controlled study to be conducted from the time of ethical approval for 12 months. Patients that will undergo coronary artery bypass graft surgery (CABG) using cardiopulmonary bypass (CBP) with single internal mammary artery harvest will be selected and randomized into 2 groups according to chronological order. The first group will receive BW (Bone-wax?, Aesculap Inc., USA) concomitant with electrocauterization, and we will use oxidized regenerated cellulose (ORC) (Surgicel NU-KNIT? Absorbable Hemostat, Ethicon Inc., USA) concomitant with electrocauterization the second group received.
One week prior to the surgery all anticoagulant and antiplatelet medications should be stopped. All coagulation tests will be done preoperatively and postoperatively including platelet counts, international normalized ratio and activated partial thromboplastin time.
We will follow the patient for one month post-operatively by our specialized wound nurse care for detection any wound infection and we will use CDC definition for surgical site infection for that purpose.
As a secondary outcome, blood drainage amounts will be recorded at the postoperative 1st, 2nd, 3rd, 6th, 12th and 24th hours. The number of units of blood and its products used will be also studied.
Demographic data will be collected through electronic data base system in our corporate after approval from the institutional review board.
Surgical technique Surgical intervention will be done through a median sternotomy with CBP, moderate hypothermia, and cold blood cardioplegia in all CABG patients.
In group I, spreading of BW on the sternal surfaces by digital pressure immediately after sternotomy and before closing the chest. In group II ORC will be cut and laid along the sternotomy over the intramedullary area immediately after sternotomy and it will be removed before closing the chest.
Routine prophylactic antibiotics will be used according to our protocol, during the skin incision. The activated coagulation time levels were measured and adjusted between 100 and 150 s postoperatively.
Clopidogrel plus Salicylic acid in case CABG surgery and Warfarin 3 mg (as starting dose) plus Enoxaparin sodium 1 mg/kg SC twice daily in case of valve surgery, will be started on the postoperative second day if no expectation for further bleeding and adequate hemostasis has been achieved.
- Being tested
- Closure of sternotomy
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of sternotomyProcedure or surgery
Also called Surgicel NU-KNIT
In group I, spreading of BW on the sternal surfaces by digital pressure immediately after sternotomy and before closing the chest. In group II ORC will be cut and laid along the sternotomy over the intramedullary area immediately after sternotomy and it will be removed before closing the chest.
| Study group | Role | What they receive |
|---|---|---|
| Bonewax | Active comparator | Spreading of BW on the sternal surfaces by digital pressure immediately after sternotomy and before closing the chest. Receives: Procedure: Closure of sternotomy |
| NU-KNIT | Active comparator | ORC will be cut and laid along the sternotomy over the intramedullary area immediately after sternotomy and it will be removed before closing the chest Receives: Procedure: Closure of sternotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective:
Determine the impact of using Oxidized regenerated cellulose (ORC) concomitant on the post-operative drainage by evaluating mean post-operative drainage between the two agents (Bone-wax® versus Surgicel)
Measured: 4 MONTHS
Secondary outcomes (1)
Secondary objective:
Determine the impact of BW with electrocauterization, and Oxidized regenerated cellulose (ORC) concomitant with electrocauterization on the rate of sternotomy wound infection after a month of the surgery, and 3 months period
Measured: 4 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start10 Sep 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery, Bone Wax, NU-KNIT, Median Sternotomy, Deep Sternal Wound Infection, Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- Randomized controlled trial with parallel stratified groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869772
- Sponsor's protocol ID
- MRC-01-21-347
- Acronym
- NBCS
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing of Surgicel NU-KNIT and Bone Wax and Their Impacts on Median Sternotomy Wound Infection and Bleeding. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06869772
- Acronym / sponsor ID
- NBCS / MRC-01-21-347
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 11 Mar 2025 (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.
Bone wax is traditionally used as part of surgical procedures to prevent bleeding from exposed spongy bone. It is an effective hemostatic device which creates a physical barrier. Unfortunately, it interferes with subsequent bone healing and increases the risk of infection in experimental studies, with its subsequent an infrequent but devastating complication, deep sternal wound infections and mediastinitis are associated with increased mortality, repeated surgical procedures, prolonged hospital stay, and increased (1-3) costs. We aim at finding whether Oxidized regenerated cellulose (ORC) concomitant with electrocauterization provided additional clinical benefit in the cardiac surgery patient who had sternotomy incision.
Primary objective: The impact of BW with electrocauterization, and Oxidized regenerated cellulose (ORC) concomitant with electrocauterization on the rate of sternotomy wound infection after a month of the surgery.
Secondary objective: The impact of using Oxidized regenerated cellulose (ORC) concomitant on the post-operative drainage and blood products need.
Study Methodology
A prospective, randomized controlled study to be conducted from the time of ethical approval for 12 months. Patients that will undergo coronary artery bypass graft surgery (CABG) using cardiopulmonary bypass (CBP) with single internal mammary artery harvest will be selected and randomized into 2 groups according to chronological order. The first group will receive BW (Bone-wax?, Aesculap Inc., USA) concomitant with electrocauterization, and we will use oxidized regenerated cellulose (ORC) (Surgicel NU-KNIT? Absorbable Hemostat, Ethicon Inc., USA) concomitant with electrocauterization the second group received.
One week prior to the surgery all anticoagulant and antiplatelet medications should be stopped. All coagulation tests will be done preoperatively and postoperatively including platelet counts, international normalized ratio and activated partial thromboplastin time.
We will follow the patient for one month post-operatively by our specialized wound nurse care for detection any wound infection and we will use CDC definition for surgical site infection for that purpose.
As a secondary outcome, blood drainage amounts will be recorded at the postoperative 1st, 2nd, 3rd, 6th, 12th and 24th hours. The number of units of blood and its products used will be also studied.
Demographic data will be collected through electronic data base system in our corporate after approval from the institutional review board.
Surgical technique Surgical intervention will be done through a median sternotomy with CBP, moderate hypothermia, and cold blood cardioplegia in all CABG patients.
In group I, spreading of BW on the sternal surfaces by digital pressure immediately after sternotomy and before closing the chest. In group II ORC will be cut and laid along the sternotomy over the intramedullary area immediately after sternotomy and it will be removed before closing the chest.
Routine prophylactic antibiotics will be used according to our protocol, during the skin incision. The activated coagulation time levels were measured and adjusted between 100 and 150 s postoperatively.
Clopidogrel plus Salicylic acid in case CABG surgery and Warfarin 3 mg (as starting dose) plus Enoxaparin sodium 1 mg/kg SC twice daily in case of valve surgery, will be started on the postoperative second day if no expectation for further bleeding and adequate hemostasis has been achieved.
Detailed description
We aim at finding whether Oxidized regenerated cellulose (ORC) concomitant with electrocauterization provided additional clinical benefit in the cardiac surgery patient who had sternotomy incision.
Primary objective: The impact of BW with electrocauterization, and Oxidized regenerated cellulose (ORC) concomitant with electrocauterization on the rate of sternotomy wound infection after a month of the surgery.
Secondary objective: The impact of using Oxidized regenerated cellulose (ORC) concomitant on the post-operative drainage and blood products need.
Study Methodology
A prospective, randomized controlled study to be conducted from the time of ethical approval for 12 months. Patients that will undergo coronary artery bypass graft surgery (CABG) using cardiopulmonary bypass (CBP) with single internal mammary artery harvest will be selected and randomized into 2 groups according to chronological order. The first group will receive BW (Bone-wax?, Aesculap Inc., USA) concomitant with electrocauterization, and we will use oxidized regenerated cellulose (ORC) (Surgicel NU-KNIT? Absorbable Hemostat, Ethicon Inc., USA) concomitant with electrocauterization the second group received.
One week prior to the surgery all anticoagulant and antiplatelet medications should be stopped. All coagulation tests will be done preoperatively and postoperatively including platelet counts, international normalized ratio and activated partial thromboplastin time.
We will follow the patient for one month post-operatively by our specialized wound nurse care for detection any wound infection and we will use CDC definition for surgical site infection for that purpose.
As a secondary outcome, blood drainage amounts will be recorded at the postoperative 1st, 2nd, 3rd, 6th, 12th and 24th hours. The number of units of blood and its products used will be also studied.
Demographic data will be collected through electronic data base system in our corporate after approval from the institutional review board.
Surgical technique Surgical intervention will be done through a median sternotomy with CBP, moderate hypothermia, and cold blood cardioplegia in all CABG patients.
In group I, spreading of BW on the sternal surfaces by digital pressure immediately after sternotomy and before closing the chest. In group II ORC will be cut and laid along the sternotomy over the intramedullary area immediately after sternotomy and it will be removed before closing the chest.
Routine prophylactic antibiotics will be used according to our protocol, during the skin incision. The activated coagulation time levels were measured and adjusted between 100 and 150 s postoperatively.
Clopidogrel plus Salicylic acid in case CABG surgery and Warfarin 3 mg (as starting dose) plus Enoxaparin sodium 1 mg/kg SC twice daily in case of valve surgery, will be started on the postoperative second day if no expectation for further bleeding and adequate hemostasis has been achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial with parallel stratified groups.
| Arm | Type | Receives |
|---|---|---|
| Bonewax | Active comparator | Procedure: Closure of sternotomySpreading of BW on the sternal surfaces by digital pressure immediately after sternotomy and before closing the chest. |
| NU-KNIT | Active comparator | Procedure: Closure of sternotomyORC will be cut and laid along the sternotomy over the intramedullary area immediately after sternotomy and it will be removed before closing the chest |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All Patients that will undergo coronary artery bypass graft surgery (CABG) using cardiopulmonary bypass (CBP) with single internal mammary artery harvest will be selected and randomized into 2 groups.
Key exclusion criteria (1 listed)
- Emergency procedures, patients with blood coagulopathies and patients who underwent re-exploration for hemorrhage after 24 hours of surgery (as sternal re-exploration increase the risk of sternal infection per se and hence this might affect the study's secondary outcome of assessing the rate of wound infection), CABG with bilateral internal mammary artery harvest, and valves surgery.
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 |
|---|---|---|
| Closure of sternotomyAlso: Surgicel NU-KNITIn group I, spreading of BW on the sternal surfaces by digital pressure immediately after sternotomy and before closing the chest. In group II ORC will be cut and laid along the sternotomy over the intramedullary area immediately after sternotomy and it will be removed before closing the chest. | Procedure or surgery | Bonewax, NU-KNIT |
Primary outcome
Primary objective:
Time frame: 4 MONTHS
Determine the impact of using Oxidized regenerated cellulose (ORC) concomitant on the post-operative drainage by evaluating mean post-operative drainage between the two agents (Bone-wax® versus Surgicel)
1 secondary outcome
Secondary objective:
Time frame: 4 MONTHS
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 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure of sternotomy in people with Cardiac Surgery, Bone Wax, NU-KNIT, Median Sternotomy, Deep Sternal Wound Infection, Surgical Site Infection, run by Hamad Medical Corporation at 1 site in Qatar.
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 1 inclusion and 1 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 11 Mar 2025. 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 Qatar. 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?
Primary objective: (time frame: 4 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2025.