CTRI/2020/05/025157
Completed
Phase 4
Single-blind, randomized study comparing clinical equivalence of Trulene�® and Prolene�® polypropylene sutures in elective primary coronary artery bypass graft surgery
Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd0 sites92 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: O- Medical and Surgical
- Sponsor
- Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd
- Enrollment
- 92
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female subjects above 18 years, scheduled for elective primary coronary artery bypass graft surgery
- •2\. Subjects who have given written informed consent
Exclusion Criteria
- •1\. Subjects with a history of CABG
- •2\. Subjects who require other combined valve intervention
- •3\. Subjects having active infection at or around the skin incision site
- •4\. Subjects with history of allergy to polypropylene or similar products
- •5\. Subjects with history of bleeding disorders
- •6\. Subjects already participating in another cardiovascular study
- •7\. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure
- •8\. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
- •9\. 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
- •10\. Subjects with mental disorder, learning disability, or language barrier
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 4
Comparative study of two suture materials (Monoglyde�® and Monocryl�®), for skin closure at cesarean deliveryHealth Condition 1: O- Medical and SurgicalCTRI/2020/06/025935Healthium Medtech Pvt Ltd132
Completed
Phase 4
A study comparing two brands of similar suture materials (Trulon�® and Ethilon�® polyamide suture), for closure of the skin following open abdominal surgeriesHealth Condition 1: O80- Encounter for full-term uncomplicated deliveryHealth Condition 2: N859- Noninflammatory disorder of uterus, unspecifiedCTRI/2020/09/027978Healthium Medtech Pvt Ltd104
Completed
Phase 4
A clinical trial to compare tissue reaction/inflammation with Trusilk�® (Healthium) and Mersilk�® (Johnson & Johnson) silk sutures post primary closure of mucosa in subjects undergoing planned surgical removal of impacted mandibular third molar at 72 hours and 7 days.Health Condition 1: O- Medical and SurgicalCTRI/2020/03/024100Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd132
Completed
Phase 4
Clinical equivalence study of two polydioxanone sutures (PD Synth and PDS) for abdominal fascial closure following midline laparotomyCTRI/2020/04/024955Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd96
Completed
Phase 4
A comparative clinical equivalence study of Trulene® and Prolene® polypropylene mesh in patients undergoing Lichtenstein open repair of primary inguinal hernia secured with sutures at 6 and 12 monthsCTRI/2020/02/023307Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd132