Clinical Investigation of Non-Absorbable Sutures, Skin Stapler and Catridge in surgery for skin closure.

Post Market Clinical Follow Up study of Non-Absorbable Sutures, Skin Stapler and Cartridge.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039306

Enrollment

300

Registered

2022-01-10

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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 Surgical Sutures,Skin Stapler and Cartidge: The non absorbable sutures should be selected and implanted depending on patientâ??s condition, surgical experience, surgical

Eligibility

Inclusion criteria

Inclusion criteria: Informed consent from the subject Subjects using the Non-absorbable sutures for general surgery, soft tissue approximation and ligation. Adult patient who are >= 18 age.

Exclusion criteria

Exclusion criteria: Subjects without informed consent from the subject. Subjects in which permanent retention of tensile strength is required. Subject who are sensitive or allergic to the raw materials of the sutures.

Design outcomes

Primary

Measure	Time frame
The primary objective of this post market clinical study is to assess the clinical performance, safety and acceptability of the Non-Absorbable Suture, Skin stapler and cartridge. Endpoints: - Quantitative determination of soft tissue approximation/ligation and wound closure action by using the non-Absorbable surgical suture and surgical skin stapler - Occurrence of wound reopening - Occurrence of wound re-rupturing after hand surgery - Any signs of superficial infection after surgery â?? Redness, Pus, Swelling - Ease of use using Likertâ??s scale (1-5) - Ease of removal using Likertâ??s Scale (1-5) Timepoint: 6 to 12 months	—

Measure

Time frame

The primary objective of this post market clinical study is to assess the clinical performance, safety and acceptability of the Non-Absorbable Suture, Skin stapler and cartridge. Endpoints: - Quantitative determination of soft tissue approximation/ligation and wound closure action by using the non-Absorbable surgical suture and surgical skin stapler - Occurrence of wound reopening - Occurrence of wound re-rupturing after hand surgery - Any signs of superficial infection after surgery â?? Redness, Pus, Swelling - Ease of use using Likertâ??s scale (1-5) - Ease of removal using Likertâ??s Scale (1-5) Timepoint: 6 to 12 months

—

Secondary

Measure	Time frame
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. Timepoint: 6 to 12 months	—

Countries

India

Contacts

Public ContactDr Murali Mohan S

Sagar Hospitals

drmurali78@gmail.com9483861505

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026