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.

A prospective study to assess the safety and performance of the non-absorbable sutures - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/077647

Enrollment

182

Registered

2024-12-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: â?¢ Presence of chronic diseases that could impair healing, such as diabetes mellitus, immune disorders or chronic steroid use â?¢ Known allergy to suture material or any components used in the suturing process

Design outcomes

Primary

Measure	Time frame
Safety of the non-absorbable suture is assessed by monitoring adverse events during periodic follow-up visits - â?¢ local inflammatory tissue reaction â?¢ local transitory irritation in response to foreign body â?¢ erythema or induration â?¢ wound dehiscence â?¢ suture sinusTimepoint: 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.	—

Measure

Time frame

Safety of the non-absorbable suture is assessed by monitoring adverse events during periodic follow-up visits - â?¢ local inflammatory tissue reaction â?¢ local transitory irritation in response to foreign body â?¢ erythema or induration â?¢ wound dehiscence â?¢ suture sinusTimepoint: 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.

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Secondary

Measure	Time frame
Performance of the non-absorbable suture is evaluated both intraoperative and postoperative. Intraoperative performance parameters - â?¢ Knot pull tensile strength â?¢ Needle attaching â?¢ Needle sharpness â?¢ Smooth passage through tissues Postoperative support offered by the suture for optimal healing of the surgical wound â?¢ Postoperative healing at surgical site without complications â?¢ Incidence of postoperative complicationsTimepoint: 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.	—

Measure

Time frame

Performance of the non-absorbable suture is evaluated both intraoperative and postoperative. Intraoperative performance parameters - â?¢ Knot pull tensile strength â?¢ Needle attaching â?¢ Needle sharpness â?¢ Smooth passage through tissues Postoperative support offered by the suture for optimal healing of the surgical wound â?¢ Postoperative healing at surgical site without complications â?¢ Incidence of postoperative complicationsTimepoint: 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.

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Countries

India

Contacts

Public ContactDr Niranjan P

Sagar Hospitals jayanagar

niranjan1982@gmail.com9844240931

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026