Post-market clinical follow-up studies are performed on a device within its intended use/purpose(s) according to the instructions for use. It is important to note that PMCF studies must be conducted according to applicable laws and regulations and should involve an appropriate methodology and follow appropriate guidance and standards. It is a precondition for placing a product on the market that conformity to the relevant Essential Requirements, including a favorable benefit/risk ratio, has been demonstrated. The PMCF is recommended also due to there may be limitations to the clinical data available in the pre-market phase. Such limitations can be addressed in Post market clinical follow up studies.  The extent of the data that will be gathered in the pre-market phase does not necessarily enable the manufacturer to detect rare complications or problems that only become apparent after wide-spread or long-term use of the device.

There are 5 types of absorbable sutures for the study

The product name and their intended use are given below:

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 – Redness, Pus, Swelling

-          Ease of use using Likert’s scale (1-5)

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.