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Post marketing study to evaluate safety and efficacy of suture material (MITSUâ?¢ Polyglactin 910) of Meril Endo Surgery Pvt. Ltd in comparision with coated (Vicrylâ?¢ Polyglactin 910) Suture during surgery for closure of surgical incision.

A prospective, multi-center, randomized, controlled, single-blind, comparative study to evaluate safety and efficacy of MITSUâ?¢ Polyglactin 910 Suture with coated Vicrylâ?¢ Polyglactin 910 Suture in closure of surgical incision. - MITSUâ?¢ Polyglactin 910 Suture

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/01/007717
Enrollment
122
Registered
2017-01-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: MITSUâ?¢ Polyglactin 910 Suture: MITSUâ?¢ Polyglactin 910 Suture in the closure of surgical incision. Control Intervention1: Vicrylâ?¢ Polyglactin 910 Suture: Vicrylâ?¢ Polyglactin 910

Sponsors

Meril EndoSurgery Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Both male and female aged gteater than or equal to 18 years old. 2) Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure. 3) Subjects scheduled for closure of surgical incision where general soft tissue approximation and/or ligation is required during elective surgery by using either MITSU Polyglactin 910 Suture of Meril Endo-Surgery Pvt. Ltd (study product) or Vicryl Polyglactin 910 Suture of Ethicon, Inc.(comparator) as per the discretion of principal investigator. 4) Subject agrees not to participate in any other investigational or invasive study for a period of 6 months. 5) Subject agrees to comply with all protocol requirements and protocol specific follow-up visits.

Exclusion criteria

Exclusion criteria: 1) Subject with history of HIV or any other systemic infections. 2) Subject in any case requiring other emergency operations (major surgical procedure). 3) Subject with on-going sepsis or septicaemia or on-going bacterial infections or on antibiotic treatment (other than prophylaxis antibiotics given prior to and post surgery). 4) Subject with history of prior surgery in recent past (within 1 month) with surgical site infection. 5) Patient with positive Urine pregnancy test (using urine pregnancy test kits) other than patient require the gynaecological surgical procedure.

Design outcomes

Primary

MeasureTime frame
Overall wound dehiscenceTimepoint: At post-procedure, 14 days (±2 days), 30 days (±7 days) and 6 months (±28 days)—

Secondary

MeasureTime frame
Rate of Superficial Incisional Surgical Site Infection (SSI)Timepoint: At baseline, post procedure/discharge, 14 days (±2 days), 30 days (±7 days) and 6 months (±28 days);Length of hospital stayTimepoint: Length of stay is calculated by subtracting day of admission from day of discharge.—

Countries

India

Contacts

Public ContactDr Ashok Thakkar

Chief Gynecologist and Infertility Specialist- Dixit Hospital

dixithospitalvapi@gmail.com9909013647

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026