Clinical Study of Absorbable Sutures
Phase 4
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/01/039498
- 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 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.
Subject in which extended approximation of tissues under stress 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 Absorbable Surgical Suture. <br/ ><br> <br/ ><br>Endpoints <br/ ><br>-Quantitative determination of soft tissue approximation/ligation and wound closure action by using the Absorbable surgical suture <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 ââ?¬â?? Redness, Pus, Swelling <br/ ><br>-Ease of use using Likertââ?¬â?¢s scale (1-5) <br/ ><br> <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.Timepoint: 6 to 12 months