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Sternal Closure in High-BMI Patients: Cable vs Wire

Sternal Closure Techniques in High-BMI Patients Undergoing Open-Heart Surgery: A Retrospective Observational Comparison of Cable and Wire Systems

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07097272
Enrollment
110
Registered
2025-07-31
Start date
2025-06-01
Completion date
2025-08-30
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Median Sternotomy, Obesity (Body Mass Index >30 kg/m2), Sternal Wound Complications

Keywords

Cardiac Surgery, Postoperative Complications, Sternum Closure, Sternal Cable, Sternal Wire

Brief 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. 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.

Interventions

None listed

Sponsors

Samsun University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Age ≥18 years 2. Body Mass Index (BMI) ≥30 kg/m² 3. Underwent primary open-heart surgery via median sternotomy 4. Sternal closure performed with either standard stainless-steel wire or multifilament sternal cable system 5. Complete and accessible perioperative clinical records

Exclusion criteria

1. Age ≥80 years 2. End-stage renal disease or chronic hemodialysis 3. Redo sternotomy 4. Early postoperative re-exploration (within 7 days) 5. Mediastinitis prior to index discharge 6. Diabetic patients with bilateral internal mammary artery (IMA) harvest 7. Diagnosed osteoporosis 8. Chronic obstructive pulmonary disease (FEV₁ \<80% and FEV₁/FVC \<70%)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Sternal Instability and Major Wound Complications90 days after surgeryThis 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.

Secondary

MeasureTime frameDescription
Intensive Care Unit Length of StayPostoperative Day 0 through ICU discharge, up to 14 daysNumber of days from admission to discharge in the intensive care unit (ICU) following open-heart surgery.
Total Hospital Length of StayPostoperative Day 0 through hospital discharge, up to 30 daysTotal number of days from surgery to hospital discharge, reflecting overall resource utilization.
Reoperation Not Related to Sternal Closure Failure30 days postoperativelyIncidence of any surgical re-intervention within 30 days postoperatively for causes unrelated to sternal instability (e.g., bleeding, tamponade).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026