Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07097272

Sternal Closure in High-BMI Patients: Cable vs Wire

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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%)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intensive Care Unit Length of Stay

    Time frame: Postoperative Day 0 through ICU discharge, up to 14 days

    Number of days from admission to discharge in the intensive care unit (ICU) following open-heart surgery.

  2. Total Hospital Length of Stay

    Time frame: Postoperative Day 0 through hospital discharge, up to 30 days

    Total number of days from surgery to hospital discharge, reflecting overall resource utilization.

  3. Reoperation Not Related to Sternal Closure Failure

    Time frame: 30 days postoperatively

    Incidence of any surgical re-intervention within 30 days postoperatively for causes unrelated to sternal instability (e.g., bleeding, tamponade).

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.