CTRI/2020/10/028240
Completed
Phase 4
Single blind, randomized study evaluating clinical equivalence of Trusteel® and Ethisteel® surgical steel suture, for sternal closure, in subjects undergoing surgical procedures by sternotomy
Healthium Medtech Pvt Ltd0 sites72 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: O- Medical and Surgical
- Sponsor
- Healthium Medtech Pvt Ltd
- Enrollment
- 72
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 4
Clinical equivalence study of two brands of polyester sutures (Trubond® and Ethibond) for fixation of the valvular prosthesis, in subjects undergoing aortic or mitral valve replacementHealth Condition 1: O- Medical and SurgicalCTRI/2020/04/024608Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd88
Active, Not Recruiting
Phase 4
A study comparing two suture materials for graft preparation in knee ligament surgeryHealth Condition 1: M668- Spontaneous rupture of other tendonsCTRI/2021/09/036704Healthium Medtech Limited
Not Yet Recruiting
Phase 3
A clinical trial to study the effects of homoeopathic medicine causticum on cases of warts through an external and internal applicatioHealth Condition 1: B079- Viral wart, unspecifiedCTRI/2022/04/041696Dr Sangram Arun Jadhav
Not Yet Recruiting
N/A
effect of lotion application in skin diseaseHealth Condition 1: L509- Urticaria, unspecifiedCTRI/2019/10/021751Parul University
Completed
Phase 4
Comparison of safety and efficaccy of levocetrizine and olopatadine in patients suffering from hives for more than 6 weeksHealth Condition 1: null- Chronic UrticariaCTRI/2011/08/001965Burdwan Medical College and Hospital120