Clinical Study of Absorbable Sutures

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/01/039498
• Lead Sponsor: Futura Surgicare Pvt Ltd

Brief Summary

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:

| | | |

| --- | --- | --- |

|**SI.NO**

**PRODUCT NAME**

**INTENDED USE**

|**1.**

Coated & Braided absorbable Polyglycolic Acid Sutures

Petcryl® sutures are indicated for use in general soft tissue approximation and in general surgery.

|**2.**

Coated and braided polyglactin 910 suture, absorbable surgical suture

Petcryl® 910 suture is indicated for use in general soft tissue approximation and/or ligation.

|**3.**

Coated and braided polyglactin 910 fast suture, absorbable surgical suture

Petcryl® 910 Fast suture is indicated for use in general soft tissue approximation and/or ligation where only short time tissue approximation is required.

|**4.**

Monofilament polydioxanone absorbable surgical suture

Duracryl sutures are indicated for use in all types of soft tissue approximation.

|**5.**

Monofilament poliglecaprone 25 absorbable surgical Suture

Petcryl® Mono sutures are indicated for use in general soft tissue approximation and/or ligation.

The primary objective of this postmarket clinical study is to assess the clinical performance, safety andacceptability of the Absorbable Surgical Suture.

Endpoints

-         Quantitativedetermination of soft tissue approximation/ligation and wound closure action byusing the Absorbable surgical suture

-         Occurrence ofwound reopening

-         Occurrence ofwound re-rupturing after hand surgery

-         Any signs ofsuperficial infection after surgery – Redness, Pus, Swelling

-         Ease of use usingLikert’s scale (1-5)

The Secondary Objective is todetermine any undesirable events under normal condition of use and identify thepresence of any new emergent risks, known and unknown residual risk. The studywill focus on identifying possible systematic misuse or off-label use of thedevice.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-17
• Last Update Posted: 2022-01-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 300

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
Endpoints	6 to 12 months
The primary objective of this post market clinical study is to assess the clinical performance, safety and acceptability of the Absorbable Surgical Suture.	6 to 12 months
-Quantitative determination of soft tissue approximation/ligation and wound closure action by using the Absorbable surgical suture	6 to 12 months
-Ease of use using Likert’s scale (1-5)	6 to 12 months
-Occurrence of wound reopening	6 to 12 months
-Occurrence of wound re-rupturing after hand surgery	6 to 12 months
-Any signs of superficial infection after surgery – Redness, Pus, Swelling	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.	6 to 12 months

Trial Locations

Locations (2)

Mukha Facial Surgery and Dental Implant Centre; 🇮🇳 Bangalore, KARNATAKA, India

Sagar Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

Mukha Facial Surgery and Dental Implant Centre

🇮🇳Bangalore, KARNATAKA, India

Dr Girish Rao

Principal investigator

9844023537

girishrao66@gmail.com