Surgical Site Infection (SSI)NCT07470112
Efficacy of Local Gentamicin Containing Collagen In Prevention of Post Stermotomy Infection In Cardiac Surgery
A study testing Gentamycin and bone wax in people with Surgical Site Infection (SSI), run by Zagazig University at 1 site in Egypt.
Trial summary
The local application of gentamicin-containing collagen implants reduces the incidence of surgical site infections in high-risk cardiac surgery patients compared to standard prophylactic measures alone. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Surgical Site Infection (SSI)
- What is being tested?
- Gentamycin and bone wax
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncontrolled hypertension and diabetes mellitus patients.
- Obesity (BMI>30 kg/m2).
- Female gender.
- Osteoporosis of the sternum.
- Chronic Obstructive Pulmonary Disease (COPD).
- Steroid therapy or immunosuppression.
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- Intraoperative intra-aortic balloon pump (IABP) use.
- Re-exploration for bleeding.
- Long time of cardiopulmonary bypass (>180 minutes).
- Redo cardiac surgery operation (elective )
Who cannot join
- o Patients with known allergies to gentamicin.
- Patients less than 18 years old.
- Off-pump cardiac surgery.
- Minimal invasive cardiac surgery.
- Elevated serum creatinine level.
- Emergent cases
- Harvesting of Bilateral internal thoracic artery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
cardiothorathic surgery department -faculty of medecine-zagazig univeristy- Egypt
Zagazig, Sharqia Province, 44519
About this study
The local application of gentamicin-containing collagen implants reduces the incidence of surgical site infections in high-risk cardiac surgery patients compared to standard prophylactic measures alone.
Read the detailed description
Surgical procedure:
- Standard median sternotomy and cannulation for cardiopulmonary bypass. All procedures will be performed on heparin bonded cardiopulmonary bypass circuits with a membrane oxygenator.
- Closure technique: Patients in our study will be divided into two groups: Gentamycin Group: Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum. (Gentamycincontaining collagen will be applied to retrosternal and between both sternal halves similar to bone wax just prior to sternal wiring (T-SHAPED. ) Control Group: Patients in this group sternum will be closed without application of local Gentamycin containing collagen.
- Conditions
- Surgical Site Infection (SSI)
- Being tested
- Gentamycin, bone wax
- Keywords
- Poststernotomy,, Surgical Site Infection (SSI), local gentamycin containig collagen
- 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.
GentamycinProcedure or surgery
Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum.
bone waxProcedure or surgery
Patients in this group sternum will be closed without application of local Gentamycin containing collagen.
| Study group | Role | What they receive |
|---|---|---|
| gentamycin | Experimental | Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum Receives: Procedure: Gentamycin |
| control | Active comparator | Patients in this group sternum will be closed without application of local Gentamycin containing collagen Receives: Procedure: bone wax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of infection severity (superficial and deep infections)
Measured: during first 3 months post operative
Incidence of adverse effects of gentamicin implants
Measured: during first 3 months post operative
Length of hospital stay
Measured: during first 3 months post operative
short-term surgical outcome checklist
Reduce mediastinits and improve sternum healing in relation to different types of of sternum closure.
Measured: during first 3 months post operative
assess degree of healing
non contrast C.T.chest done to assess degree of healing by The 6-Point CT Score (Stacy Score):
0 Non-union No evidence of bone bridging; wide gap.
- Minimal union Rare/slight bone bridging across the osteotomy.
- Mild union Less than 25% bone bridging.
- Moderate union 25% to 50% bone bridging.
- Near-complete More than 50% bone bridging with high stability.
- Complete union Sternal halves well-aligned; no perceptible gap; looks like normal bone.
Measured: after 3 months non contrast C.T.chest done to assess degree of healing by the Six Points Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start20 May 2025
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site Infection (SSI)Studies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Gentamycin Group: Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum. (Gentamycincontaining collagen will be applied to retrosternal and between both sternal halves similar to bone wax just prior to sternal wiring (T-SHAPED. )
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr Elsayed Tawfek Ibrahim, Zagazig University
- Investigators
- amr tawfeek, Principal investigator, cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470112
- Sponsor's protocol ID
- ZU-IRB#1355/18-5-2025
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: by publication of the study
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Local Gentamicin Containing Collagen In Prevention of Post Stermotomy Infection In Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07470112
- Acronym / sponsor ID
- ZU-IRB#1355/18-5-2025
- Conditions
- Surgical Site Infection (SSI)
- Keywords
- Poststernotomy,, Surgical Site Infection (SSI), local gentamycin containig collagen
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 May 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 13 Mar 2026 (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.
The local application of gentamicin-containing collagen implants reduces the incidence of surgical site infections in high-risk cardiac surgery patients compared to standard prophylactic measures alone.
Detailed description
Surgical procedure:
- Standard median sternotomy and cannulation for cardiopulmonary bypass. All procedures will be performed on heparin bonded cardiopulmonary bypass circuits with a membrane oxygenator.
- Closure technique: Patients in our study will be divided into two groups: Gentamycin Group: Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum. (Gentamycincontaining collagen will be applied to retrosternal and between both sternal halves similar to bone wax just prior to sternal wiring (T-SHAPED. ) Control Group: Patients in this group sternum will be closed without application of local Gentamycin containing collagen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Gentamycin Group: Patients in this group had local sternal Gentamycin containing collagen between two edges of the sternum. (Gentamycincontaining collagen will be applied to retrosternal and between both sternal halves similar to bone wax just prior to sternal wiring (T-SHAPED. )
| Arm | Type | Receives |
|---|---|---|
| gentamycin | Experimental | Procedure: GentamycinPatients in this group had local sternal Gentamycin containing collagen between two edges of the sternum |
| control | Active comparator | Procedure: bone waxPatients in this group sternum will be closed without application of local Gentamycin containing collagen |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Uncontrolled hypertension and diabetes mellitus patients.
- Obesity (BMI>30 kg/m2).
- Female gender.
- Osteoporosis of the sternum.
- Chronic Obstructive Pulmonary Disease (COPD).
Key exclusion criteria (7 listed)
- o Patients with known allergies to gentamicin.
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 |
|---|---|---|
| GentamycinPatients in this group had local sternal Gentamycin containing collagen between two edges of the sternum. | Procedure or surgery | gentamycin |
| bone waxPatients in this group sternum will be closed without application of local Gentamycin containing collagen. | Procedure or surgery | control |
Primary outcome
Rate of infection severity (superficial and deep infections)
Time frame: during first 3 months post operative
Incidence of adverse effects of gentamicin implants
Time frame: during first 3 months post operative
Length of hospital stay
Time frame: during first 3 months post operative
short-term surgical outcome checklist
Time frame: during first 3 months post operative
Reduce mediastinits and improve sternum healing in relation to different types of of sternum closure.
assess degree of healing
Time frame: after 3 months non contrast C.T.chest done to assess degree of healing by the Six Points Scale
non contrast C.T.chest done to assess degree of healing by The 6-Point CT Score (Stacy Score): 0 Non-union No evidence of bone bridging; wide gap. 1. Minimal union Rare/slight bone bridging across the osteotomy. 2. Mild union Less than 25% bone bridging. 3. Moderate union 25% to 50% bone bridging. 4. Near-complete More than 50% bone bridging with high stability. 5. Complete union Sternal halves well-aligned; no perceptible gap; looks like normal bone.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes. by publication of the study
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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.
amr tawfeek principal investigator
cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentamycin and bone wax in people with Surgical Site Infection (SSI), run by Zagazig University at 1 site in Egypt.
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 10 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of infection severity (superficial and deep infections) (time frame: during first 3 months post operative). The study lists 5 primary outcomes in all. 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 13 Mar 2026.