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.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/077644

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: 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, inc

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Safety of the 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?¢ sututre sinusTimepoint: 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.	—

Measure

Time frame

Safety of the 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?¢ sututre sinusTimepoint: 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.

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Secondary

Measure	Time frame
Performance of the 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: 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.	—

Measure

Time frame

Performance of the 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: 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.

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Countries

India

Contacts

Public ContactDr Niranjan P

Sagar Hospitals jayanagar

niranjan1982@gmail.com09844240931

Outcome results

None listed

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