A study comparing use of two surgical steel suture materials for closure of breastbone after cardiac surgery

Single blind, randomized study evaluating clinical equivalence of TrusteelÂ® and EthisteelÂ® surgical steel suture, for sternal closure, in subjects undergoing surgical procedures by sternotomy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028240

Enrollment

Registered

2020-10-05

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: TrusteelÂ® steel suture: TrusteelÂ® suture (Healthium) (non-absorbable, sterile surgical steel suture composed of 316LVM grade stainless steel used in sternum closure) Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subjects aged 18-70 years, scheduled for median sternotomy, for surgical procedures on heart, great vessels and mediastinal lesions 2. Subjects who have given written informed consent

Exclusion criteria

Exclusion criteria: 1. Subjects with a history of median sternotomy 2. ASA-V classified subjects 3. Subjects having active infection at or around the -skin incision site 4. Subjects who are pregnant 5. Subjects with history of allergy to steel or similar products 6. Subjects with history of bleeding disorders 7. Subjects already participating in another cardiovascular or similar study 8. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure 9. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator 10. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center 11. Subjects with mental disorder, learning disability, or language barrier 12. Other indication-based exclusion, in opinion of investigator

Design outcomes

Primary

Measure	Time frame
1. To compare the rate of sternal dehiscence after median sternotomy closureTimepoint: Day 3, At discharge, 6 weeks after discharge, 12 weeks after discharge, 24 weeks after discharge	—

Secondary

Measure	Time frame
1. To evaluate all-cause mortality 2. To evaluate other surgical complications of median sternotomy closure 3. To assess overall intraoperative handling of suture 4. To assess the amount of time subject takes to return back to work and to normal day to day activities 5. To evaluate material problems and other adverse events 6. To evaluate overall subject satisfaction score and well-being in the two groupsTimepoint: Day 3, At discharge, 6 weeks after discharge, 12 weeks after discharge, 24 weeks after discharge	—

Measure

Time frame

1. To evaluate all-cause mortality 2. To evaluate other surgical complications of median sternotomy closure 3. To assess overall intraoperative handling of suture 4. To assess the amount of time subject takes to return back to work and to normal day to day activities 5. To evaluate material problems and other adverse events 6. To evaluate overall subject satisfaction score and well-being in the two groupsTimepoint: Day 3, At discharge, 6 weeks after discharge, 12 weeks after discharge, 24 weeks after discharge

—

Countries

India

Contacts

Public ContactDr Ashok Kumar Moharana

Healthium Medtech Pvt.Ltd.

ashok.m@healthiummedtech.com9717887751

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026