Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Absorbable Surgical sutures: Absorbable sutures should be selected and implanted depending on the patient�s condition, surgical experience, surgical technique and wound size.
Pec
Sponsors
Futura Surgicare Pvt Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this post market clinical study is to assess the clinical performance, safety and acceptability of the Absorbable Surgical Suture. Endpoints - Quantitative determination of soft tissue approximation/ligation and wound closure action by using the Absorbable surgical suture - Occurrence of wound reopening - Occurrence of wound re-rupturing after hand surgery - Any signs of superficial infection after surgery ââ?¬â?? Redness, Pus, Swelling - Ease of use using Likertââ?¬â?¢s scale (1-5) Timepoint: 6 to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Murali Mohan S
Sagar Hospitals
Outcome results
None listed