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

Phase 4

Completed

Conditions: Health Condition 1: O- Medical and Surgical

Registration Number: CTRI/2020/10/028240

Lead Sponsor: Healthium Medtech Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 72

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. To evaluate all-cause mortality <br/ ><br>2. To evaluate other surgical complications of median sternotomy closure <br/ ><br>3. To assess overall intraoperative handling of suture <br/ ><br>4. To assess the amount of time subject takes to return back to work and to normal day to day activities <br/ ><br>5. To evaluate material problems and other adverse events <br/ ><br>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