Clinical Investigation of Non-Absorbable Sutures, Skin Stapler and Catridge in surgery for skin closure.
Phase 4
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/01/039306
- Lead Sponsor
- Futura Surgicare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Informed consent from the subject
Subjects using the Non-absorbable sutures for general surgery, soft tissue approximation and ligation.
Adult patient who are >= 18 age.
Exclusion Criteria
Subjects without informed consent from the subject.
Subjects in which permanent retention of tensile strength is required.
Subject who are sensitive or allergic to the raw materials of the sutures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this post market clinical study is to assess the clinical performance, safety and acceptability of the Non-Absorbable Suture, Skin stapler and cartridge. <br/ ><br> <br/ ><br>Endpoints: <br/ ><br> <br/ ><br>-Quantitative determination of soft tissue approximation/ligation and wound closure action by using the non-Absorbable surgical suture and surgical skin stapler <br/ ><br>-Occurrence of wound reopening <br/ ><br>-Occurrence of wound re-rupturing after hand surgery <br/ ><br>-Any signs of superficial infection after surgery â?? Redness, Pus, Swelling <br/ ><br>-Ease of use using Likertâ??s scale (1-5) <br/ ><br>-Ease of removal using Likertâ??s Scale (1-5) <br/ ><br>Timepoint: 6 to 12 months
- Secondary Outcome Measures
Name Time Method The Secondary Objective is to determine any undesirable events under normal condition of use and identify the presence of any new emergent risks, known and unknown residual risk. The study will focus on identifying possible systematic misuse or off-label use of the device. <br/ ><br> <br/ ><br>Timepoint: 6 to 12 months