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CTRI Number  CTRI/2024/12/077644 [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 use of absorbable sutures in a surgical procedure typically aims to promote healing and minimize the need for follow-up procedures to remove sutures. 
Scientific Title of Study   A prospective study to assess the safety and performance of the 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

Bangalore
KARNATAKA
560041
India 
Phone  09844240931  
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

Bangalore
KARNATAKA
560041
India 
Phone  09844240931  
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

Bangalore
KARNATAKA
560041
India 
Phone  09844240931  
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 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 = 2  
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-635109
Dharmapuri
TAMIL NADU 		 07708997222

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 
 
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 
Intervention  Absorbable sutures   Braided & Coated Polyglycolic Acid Sterile Synthetic Absorbable Surgical Suture U.S.P are indicated for use in general soft tissue approximation and/or ligation, including use in plastic & ophthalmic surgery, but not for use in cardiovascular and neurological tissues. Braided & Coated Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture U.S.P are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. Monofilament Polydioxanone Sterile Synthetic Absorbable Surgical Suture is intended for use in soft tissue approximation, and ophthalmic surgery (other than contact with cornea and sclera). Monofilament Polydioxanone Absorbable Surgical Suture is not indicated in paediatric tissue, and adult cardiovascular tissue, microsurgery, and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. 
Comparator Agent  NIL  NIL 
 
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 absorbable sutures are indicated - use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery.
3.Subject willingness to provide informed consent and comply with study procedures and follow-up visits
 
 
ExclusionCriteria 
Details  1.Presence of chronic diseases that could impair healing, such as diabetes mellitus, immune disorders or chronic steroid use
2.Known allergy to suture material or any components used in the suturing process
3.Cardiovascular and neurological tissues suturing
4.Vulnerable population such as lactating mothers, pregnant women and pediatric population 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Safety of the 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
• sututre sinus  		 Subjects will have regular follow-up
appointments with the investigator, post-operative on Day 7,
Day 30 and telephonic follow up on Day 100 and Day 180(
applicable only for Monofilament Polydioxanone Absorbable
Surgical Suture).
During this period assessments of each subject at different visits shall be recorded in the CRF. 
 
Secondary Outcome  
Outcome  TimePoints 
Performance of the 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  		 Subjects will have regular follow-up
appointments with the investigator, post-operative on Day 7,
Day 30 and telephonic follow up on Day 100 and Day 180(
applicable only for Monofilament Polydioxanone Absorbable
Surgical Suture).
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)="182" 
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 absorbable sutures. .
Type of Study-The study will be a prospective, interventional, multi-centric 
and open label study. 
Study Period-6 Months 

Results:

Monofilament Polydioxanone Sterile Synthetic Absorbable Surgical Suture-

 A total of 60 subjects were recruited in the clinical study. Among the 60 enrolled subjects, 29(48%) were male and 31(52%) 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 Polydioxanone Sterile Synthetic Absorbable Surgical Suture 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.
Monofilament Polydioxanone Sterile Synthetic Absorbable Surgical Suture provided below mentioned clinical benefits during the study:
- 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, second and the third (telephonic follow-up) and fourth follow up (telephonic follow-up) for all 60 subjects. All 60 subjects who completed the evaluation demonstrated complete healing of the surgical site.
In all use cases, all the users rated the product’s performance as very good, indicating consistent and satisfactory performance across applications.
In all use cases, all the users rated their overall satisfaction with the product as very good, reflecting a positive user experience.

Braided & Coated Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture U.S.P-
A total of 61 subjects were recruited in the clinical study. Among the 61 enrolled subjects, 32(52%) were male and 29(48%) were female.
The product fulfilled its intended use across all evaluated cases, with users providing favourable responses for both suture variants - with and without needle.
The clinical safety parameter analysis of Braided & Coated Polyglactin 910 Sterile Synthetic 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 Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture U.S.P provided below mentioned clinical benefits during the study:
- 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 61 subjects. All 61 subjects who completed the evaluation demonstrated complete healing of the surgical site.
In all use cases, all the users rated the product’s performance as very good, indicating consistent and satisfactory performance across applications.
In all use cases, all the users rated their overall satisfaction with the product as very good, reflecting a positive user experience.

Braided & Coated Polyglycolic Acid Sterile Synthetic Absorbable Surgical Suture U.S.P-

A total of 61 subjects were recruited in the clinical study. Among the 61 enrolled subjects, 32(52%) were male and 29(48%) were female.
The product fulfilled its intended use across all evaluated cases, with users providing favourable responses for both suture variants - with and without needle.
The clinical safety parameter analysis of Braided & Coated Polyglycolic Acid Sterile Synthetic 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 Polyglycolic Acid Sterile Synthetic Absorbable Surgical Suture U.S.P provided below mentioned clinical benefits during the study:
- 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 61 subjects. All 61 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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