Sternal Closure in High-BMI Patients: Cable vs Wire

NCT07097272 | Active Not Recruiting

• 1 other identifier: SamsunKVC SCW
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days after surgery

Secondary Outcomes (3)

• Intensive Care Unit Length of Stay

  Postoperative Day 0 through ICU discharge, up to 14 days

• Total Hospital Length of Stay

  Postoperative Day 0 through hospital discharge, up to 30 days

• Reoperation Not Related to Sternal Closure Failure

  30 days postoperatively

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University Faculty of medicine

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Postoperative Complications

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 31, 2025
• Study Start: June 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: August 30, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-06

Locations

TU (1)