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CTRI Number  CTRI/2024/12/077647 [Registered on: 04/12/2024] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   An intervention involving the non-absorbable sutures are used in areas that allow easy removal of suture after healing (e.g.skin closure) or when long term suture strength is required. 
Scientific Title of Study   A prospective study to assess the safety and performance of the non-absorbable sutures 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niranjan P 
Designation  General Surgeon 
Affiliation  Sagar Hospitals jayanagar 
Address  Ground floor Sagar Hospitals, Jayanagar, #44/54, 30th Cross road Tilak Nagar Jayanagar Bengaluru-560041 Karnataka, India

Bangalore
KARNATAKA
560041
India 
Phone  9844240931  
Fax    
Email  niranjan1982@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Niranjan P 
Designation  General Surgeon 
Affiliation  Sagar Hospitals jayanagar 
Address  Ground floor Sagar Hospitals, Jayanagar, #44/54, 30th Cross road Tilak Nagar Jayanagar Bengaluru-560041 Karnataka, India

Bangalore
KARNATAKA
560041
India 
Phone  9844240931  
Fax    
Email  niranjan1982@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Niranjan P 
Designation  General Surgeon 
Affiliation  Sagar Hospitals jayanagar 
Address  Ground floor Sagar Hospitals, Jayanagar, #44/54, 30th Cross road Tilak Nagar Jayanagar Bengaluru-560041 Karnataka, India

Bangalore
KARNATAKA
560041
India 
Phone  9844240931  
Fax    
Email  niranjan1982@gmail.com  
 
Source of Monetary or Material Support  
AQMEN MEDTECH PRIVATE LIMITED 
 
Primary Sponsor  
Name  AQMEN MEDTECH PRIVATE LIMITED  
Address  Sy. No. 68/69, Varadanahalli Village, Bashettihally Gram panchayat, Kasaba hobli, Doddaballapur Taluk, Bengaluru Rural 561203 
Type of Sponsor  Other [Medical devices manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasanaraj S  Sabhari Eye Care Hospital & Retina Centre   ground floor,No 33/3, Rajeev Nagar, Bagalur Road, Hosur
Dharmapuri
TAMIL NADU 		 7708997222

prasannaraj1309@gmail.com 
Dr Niranjan P  Sagar Hospital, Jayanagar   Ground floor,#44/54, 30th Cross road Tilak Nagar Jayanagar Bengaluru-560041
Bangalore
KARNATAKA 		 9844240931

niranjan1982@gmail.com 
Dr Murali Mohan  Synapse Neuro Center Multi-specialty clinic  basement,room no. 1,Synapse Neuro Center Multi-specialty clinic Yelahanka New Town,Bangalore
Bangalore
KARNATAKA 		 9483861505

drmurali78@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Non-Absorbable Sutures  Monofilament Polypropylene Sterile Non Absorbable Surgical Suture U.S.P is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical tissue. Monofilament Polyamide (Nylon) Sterile Non Absorbable Surgical Suture U.S.P is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical tissues. Black Braided Silk Sterile Non Absorbable Surgical Suture U.S.P is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical tissues. Braided & Coated Polyester Sterile Non Absorbable Surgical Suture U.S.P is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical tissues. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Participants adult , irrespective of the gender
2.Subjects requiring surgical procedures where non
absorbable sutures are indicated - use in general soft tissue approximation and/or ligation, including use in ophthalmic and neurosurgical tissues.
3.Subject willingness to provide informed consent and comply with study procedures and follow-up visits  
 
ExclusionCriteria 
Details  • Presence of chronic diseases that could impair healing,
such as diabetes mellitus, immune disorders or chronic
steroid use
• Known allergy to suture material or any components used in the suturing process 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety of the non-absorbable suture is assessed by monitoring
adverse events during periodic follow-up visits -
• local inflammatory tissue reaction
• local transitory irritation in response to foreign body
• erythema or induration
• wound dehiscence
• suture sinus 		 A total of 3 follow-up visits are performed on day 7, day 30 and day 100.
During this period assessments of each subject at different visits shall be recorded in the CRF.  
 
Secondary Outcome  
Outcome  TimePoints 
Performance of the non-absorbable suture is evaluated both intraoperative and
postoperative.
Intraoperative performance parameters -
• Knot pull tensile strength
• Needle attaching
• Needle sharpness
• Smooth passage through tissues
Postoperative support offered by the suture for optimal healing of the surgical wound
• Postoperative healing at surgical site without complications
• Incidence of postoperative complications  		 A total of 3 follow-up visits are performed on day 7, day 30 and day 100.
During this period assessments of each subject at different visits shall be recorded in the CRF.  
 
Target Sample Size   Total Sample Size="182"
Sample Size from India="182" 
Final Enrollment numbers achieved (Total)= "182"
Final Enrollment numbers achieved (India)="172" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   16/12/2024 
Date of Study Completion (India) 20/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Title of Study:A prospective study to assess the safety and performance of 
the non-absorbable sutures 
Type of Study:The study will be a prospective, interventional, multi-centric 
and open label study.
Study Period:6 Months

Results:

Monofilament Polyamide (Nylon) Sterile Non- Absorbable Surgical Suture U.S.P 

A total of 46 subjects were recruited in the clinical study. Among the 46 enrolled subjects, 25 (54%) were male and 21 (46%) were female.
The product fulfilled its intended use across all evaluated cases, with users providing favourable responses for both suture variants — with and without a needle.
The clinical safety parameter analysis of Monofilament Polyamide (Nylon) Non-Absorbable Surgical Suture indicates that users have provided consistently favourable responses across all use cases, supporting its clinical safety profile.
The majority of users have rated the performance of the suture product as good, suggesting overall user satisfaction.
Monofilament Polyamide (Nylon) Non-Absorbable Surgical Suture provided below mentioned clinical benefits during the study:
- Provide excellent tissue support for wound healing
- Adequate tensile strength, which ensures that the suture remains intact during the healing process
- Good knot security

No complications or adverse events were observed during the first follow-up visit, second follow-up visit and third follow-up (telephonic follow-up) for all 46 subjects. All 46 subjects who completed the evaluation demonstrated complete healing of the surgical site.
In all use cases, the majority of users rated the product’s performance as good, indicating consistent and satisfactory performance across applications.
In all use cases, the majority of users rated their overall satisfaction with the product as good, reflecting a positive user experience.

Braided & Coated Polyester sterile Non-Absorbable Surgical Suture U.S.P

A total of 35 subjects were recruited in the clinical study. Among the 35 enrolled subjects, 19 (54%) were male and 16 (46%) were female.
The product fulfilled its intended use across all evaluated cases, with users providing favourable responses for both suture variants, with and without a needle.
The clinical safety parameter analysis of Braided & Coated Polyester sterile Non-Absorbable Surgical Suture U.S.P indicates that users have provided consistently favourable responses across all use cases, supporting its clinical safety profile.
All the users have rated the performance of the suture product as good, suggesting overall user satisfaction.
Braided & Coated Polyester sterile Non-Absorbable Surgical Suture U.S.P provided below mentioned clinical benefits during the study:
- Provide excellent tissue support for wound healing
- Adequate tensile strength, which ensures that the suture remains intact during the healing process
- Good knot security

No complications or adverse events were observed during the first follow-up visit, second follow-up visit and third follow-up (telephonic follow-up) for all 35 subjects. All 35 subjects who completed the evaluation demonstrated complete healing of the surgical site.
In all use cases, the users rated the product’s performance as very good, indicating consistent and satisfactory performance across applications.
In all use cases, the users rated their overall satisfaction with the product as good, reflecting a positive user experience.

Monofilament Polypropylene Sterile Non-Absorbable Surgical Suture U.S.P 

A total of 46 subjects were recruited in the clinical study. Among the 46 enrolled subjects, 25 (54%) were male and 21 (46%) were female.
The product fulfilled its intended use across all evaluated cases, with users providing favourable responses for both suture variants, with and without a needle.
The clinical safety parameter analysis of Monofilament Polypropylene Sterile Non -Absorbable Surgical Suture U.S.P indicates that users have provided consistently favourable responses across all use cases, supporting its clinical safety profile.
The majority of users have rated the performance of the suture product as good, suggesting overall user satisfaction.
Monofilament Polypropylene Sterile Non -Absorbable Surgical Suture U.S.P provided below mentioned clinical benefits during the study:
- Provide excellent tissue support for wound healing
- Adequate tensile strength, which ensures that the suture remains intact during the healing process
- Good knot security

No complications or adverse events were observed during the first follow-up visit, second follow-up visit and third follow-up (telephonic follow-up) for all 46 subjects. All 46 subjects who completed the evaluation demonstrated complete healing of the surgical site. 
In all use cases, the majority of users rated the product’s performance as very good, indicating consistent and satisfactory performance across applications.
In all use cases, the majority of users rated their overall satisfaction with the product as very good, reflecting a positive user experience.

Black Braided Silk Sterile Non-Absorbable Surgical Suture U.S.P 

A total of 45 subjects were recruited in the clinical study. Among the 45 enrolled subjects, 21 (47%) were male and 24 (53%) were female.
The product fulfilled its intended use across all evaluated cases, with users providing favorable responses for both suture variants, with and without a needle.
The clinical safety parameter analysis of Black Braided Silk Non-Absorbable Surgical Suture indicates that users have provided consistently favorable responses across all use cases, supporting its clinical safety profile.
The majority of users have rated the performance of the suture product as good, suggesting overall user satisfaction.
Black Braided Silk Non-Absorbable Surgical Suture provided below mentioned clinical benefits during the study:
- Provide excellent tissue support for wound healing
- Adequate tensile strength, which ensures that the suture remains intact during the healing process
- Good knot security
No complications or adverse events were observed during the first follow-up visit, second follow-up visit and third follow-up (telephonic follow-up) for all 45 subjects. All 45 subjects who completed the evaluation demonstrated complete healing of the surgical site.
In all use cases, the majority of users rated the product’s performance as very good, indicating consistent and satisfactory performance across applications.
In all use cases, the majority of users rated their overall satisfaction with the product as very good, reflecting a positive user experience.


 
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