Sternal Wound ComplicationsNCT07097272
Sternal Closure in High-BMI Patients: Cable vs Wire
An observational study of Sternal Wound Complications and Obesity (Body Mass Index >30 kg/m2), run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective study compares two sternal closure techniques-standard stainless-steel wires and rigid cable systems-in adult patients with a body mass index (BMI) ≥30 who underwent open-heart surgery between January 1, 2020, and December 31, 2024. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sternal Wound Complications, Obesity (Body Mass Index >30 kg/m2), Median Sternotomy
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 30 Aug 2025
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes adult patients (≥18 years) with a body mass index (BMI) of 30 kg/m² or higher who underwent primary open-heart surgery via median sternotomy at a single tertiary cardiovascular surgery center. All patients received sternal closure using either standard stainless-steel wire or a rigid multifilament cable system. Patients with additional indications for rigid sternal fixation-such as advanced age, dialysis, reoperation, or osteoporosis-were excluded to isolate the effect of BMI on outcomes.
Who may be able to join
- Age ≥18 years
- Body Mass Index (BMI) ≥30 kg/m²
- Underwent primary open-heart surgery via median sternotomy
- Sternal closure performed with either standard stainless-steel wire or multifilament sternal cable system
- Complete and accessible perioperative clinical records
Who cannot join
- Age ≥80 years
- End-stage renal disease or chronic hemodialysis
- Redo sternotomy
- Early postoperative re-exploration (within 7 days)
- Mediastinitis prior to index discharge
- Diabetic patients with bilateral internal mammary artery (IMA) harvest
- Diagnosed osteoporosis
- Chronic obstructive pulmonary disease (FEV₁ <80% and FEV₁/FVC <70%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sternal Closure Techniques in High-BMI Patients Undergoing Open-Heart Surgery: A Retrospective Observational Comparison of Cable and Wire Systems
This retrospective study compares two sternal closure techniques-standard stainless-steel wires and rigid cable systems-in adult patients with a body mass index (BMI) ≥30 who underwent open-heart surgery between January 1, 2020, and December 31, 2024. The study aims to evaluate the incidence of sternal instability, wound infections, reoperation, and length of stay in the intensive care unit and hospital. Findings may help inform surgical decision-making for high-BMI patients.
Read the detailed description
Elevated body-mass index (BMI ≥ 30 kg/m²) is an established risk factor for sternal wound complications after median sternotomy, yet consensus is lacking on the optimal closure technique in this high-risk subgroup. Conventional monofilament stainless-steel wiring remains the worldwide standard because it is inexpensive and familiar, but multifilament cable systems provide greater fatigue strength and more uniform load distribution in bench testing and early clinical reports. Previous meta-analyses report conflicting results-some indicating fewer sternal complications with rigid fixation, others showing no clear benefit-largely because they pool heterogeneous populations in which obesity is often only one of many overlapping risk factors. The present study isolates the effect of BMI by retrospectively analysing all adult patients (≥18 years) with BMI ≥ 30 kg/m² who underwent primary open-heart surgery at a single tertiary centre from 1 January 2020 through 31 December 2024. Patients are stratified by the sternal closure method actually used-standard simple/figure-of-eight wires versus a commercially available rigid cable system (RTI Surgical Sternal Cable). By excluding other indications for rigid fixation (eg, age ≥ 80, dialysis, osteoporosis, COPD, bilateral internal mammary harvest, mediastinitis, early re-exploration, re-do sternotomy), the analysis aims to discern whether obesity alone modifies the relative performance of the two techniques. De-identified peri-operative data are extracted from electronic records under institutional ethics approval, and pre-specified statistical comparisons will quantify associations between closure method and postoperative sternal instability, surgical site infection, need for reoperation, and resource utilisation (ICU and total hospital length of stay). Findings are expected to refine evidence-based recommendations for sternal closure in high-BMI cardiac-surgery patients.
- Conditions
- Sternal Wound Complications, Obesity (Body Mass Index >30 kg/m2), Median Sternotomy, Cardiac Surgery
- Keywords
- Cardiac Surgery, Postoperative Complications, Sternum Closure, Sternal Cable, Sternal Wire
- Medical subject headings
- Obesity, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| standard wire group | Patients with BMI ≥30 who underwent median sternotomy and had sternal closure using standard stainless-steel wire. | |
| cable system group | Patients with BMI ≥30 who underwent median sternotomy and had sternal closure using the RTI Surgical Sternal Cable System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Sternal Instability and Major Wound Complications
This outcome measures the rate of sternal instability (e.g., dehiscence, nonunion, displacement requiring intervention) and major sternal wound complications (e.g., deep sternal wound infection, mediastinitis, or reoperation for closure failure) in patients with BMI ≥30 undergoing open-heart surgery. The results will be compared between patients whose sternum was closed with standard stainless-steel wire versus those treated with a multifilament sternal cable system.
Measured: 90 days after surgery
Secondary outcomes (3)
Intensive Care Unit Length of Stay
Number of days from admission to discharge in the intensive care unit (ICU) following open-heart surgery.
Measured: Postoperative Day 0 through ICU discharge, up to 14 days
Total Hospital Length of Stay
Total number of days from surgery to hospital discharge, reflecting overall resource utilization.
Measured: Postoperative Day 0 through hospital discharge, up to 30 days
Reoperation Not Related to Sternal Closure Failure
Incidence of any surgical re-intervention within 30 days postoperatively for causes unrelated to sternal instability (e.g., bleeding, tamponade).
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2025
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sternal Wound ComplicationsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097272
- Sponsor's protocol ID
- SamsunKVC SCW
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sternal Closure Techniques in High-BMI Patients Undergoing Open-Heart Surgery: A Retrospective Observational Comparison of Cable and Wire Systems
- ClinicalTrials.gov ID
- NCT07097272
- Acronym / sponsor ID
- SamsunKVC SCW
- Conditions
- Sternal Wound Complications, Obesity (Body Mass Index >30 kg/m2), Median Sternotomy, Cardiac Surgery
- Keywords
- Cardiac Surgery, Postoperative Complications, Sternum Closure, Sternal Cable, Sternal Wire
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 31 Jul 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.
This retrospective study compares two sternal closure techniques-standard stainless-steel wires and rigid cable systems-in adult patients with a body mass index (BMI) ≥30 who underwent open-heart surgery between January 1, 2020, and December 31, 2024. The study aims to evaluate the incidence of sternal instability, wound infections, reoperation, and length of stay in the intensive care unit and hospital. Findings may help inform surgical decision-making for high-BMI patients.
Detailed description
Elevated body-mass index (BMI ≥ 30 kg/m²) is an established risk factor for sternal wound complications after median sternotomy, yet consensus is lacking on the optimal closure technique in this high-risk subgroup. Conventional monofilament stainless-steel wiring remains the worldwide standard because it is inexpensive and familiar, but multifilament cable systems provide greater fatigue strength and more uniform load distribution in bench testing and early clinical reports. Previous meta-analyses report conflicting results-some indicating fewer sternal complications with rigid fixation, others showing no clear benefit-largely because they pool heterogeneous populations in which obesity is often only one of many overlapping risk factors. The present study isolates the effect of BMI by retrospectively analysing all adult patients (≥18 years) with BMI ≥ 30 kg/m² who underwent primary open-heart surgery at a single tertiary centre from 1 January 2020 through 31 December 2024. Patients are stratified by the sternal closure method actually used-standard simple/figure-of-eight wires versus a commercially available rigid cable system (RTI Surgical Sternal Cable). By excluding other indications for rigid fixation (eg, age ≥ 80, dialysis, osteoporosis, COPD, bilateral internal mammary harvest, mediastinitis, early re-exploration, re-do sternotomy), the analysis aims to discern whether obesity alone modifies the relative performance of the two techniques. De-identified peri-operative data are extracted from electronic records under institutional ethics approval, and pre-specified statistical comparisons will quantify associations between closure method and postoperative sternal instability, surgical site infection, need for reoperation, and resource utilisation (ICU and total hospital length of stay). Findings are expected to refine evidence-based recommendations for sternal closure in high-BMI cardiac-surgery patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard wire group | – | –Patients with BMI ≥30 who underwent median sternotomy and had sternal closure using standard stainless-steel wire. |
| cable system group | – | –Patients with BMI ≥30 who underwent median sternotomy and had sternal closure using the RTI Surgical Sternal Cable System. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adult patients (≥18 years) with a body mass index (BMI) of 30 kg/m² or higher who underwent primary open-heart surgery via median sternotomy at a single tertiary cardiovascular surgery center. All patients received sternal closure using either standard stainless-steel wire or a rigid multifilament cable system. Patients with additional indications for rigid sternal fixation-such as advanced age, dialysis, reoperation, or osteoporosis-were excluded to isolate the effect of BMI on outcomes.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Body Mass Index (BMI) ≥30 kg/m²
- Underwent primary open-heart surgery via median sternotomy
- Sternal closure performed with either standard stainless-steel wire or multifilament sternal cable system
- Complete and accessible perioperative clinical records
Key exclusion criteria (8 listed)
- Age ≥80 years
- End-stage renal disease or chronic hemodialysis
- Redo sternotomy
- Early postoperative re-exploration (within 7 days)
- Mediastinitis prior to index discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Sternal Instability and Major Wound Complications
Time frame: 90 days after surgery
This outcome measures the rate of sternal instability (e.g., dehiscence, nonunion, displacement requiring intervention) and major sternal wound complications (e.g., deep sternal wound infection, mediastinitis, or reoperation for closure failure) in patients with BMI ≥30 undergoing open-heart surgery. The results will be compared between patients whose sternum was closed with standard stainless-steel wire versus those treated with a multifilament sternal cable system.
3 secondary outcomes
Intensive Care Unit Length of Stay
Time frame: Postoperative Day 0 through ICU discharge, up to 14 days
Total Hospital Length of Stay
Time frame: Postoperative Day 0 through hospital discharge, up to 30 days
Reoperation Not Related to Sternal Closure Failure
Time frame: 30 days postoperatively
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 31 Jul 2025.
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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.
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?
An observational study of Sternal Wound Complications and Obesity (Body Mass Index >30 kg/m2), run by Samsun University at 1 site in Turkey (Türkiye).
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 5 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 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 Turkey (Türkiye). 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?
Incidence of Sternal Instability and Major Wound Complications (time frame: 90 days after surgery). 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 31 Jul 2025.